Cetacaine Liquid

Pronunciation: bue-TAM-ben/TE-tra-kane/BEN-zoe-kane
Generic Name: Butamben/Tetracaine/Benzocaine
Brand Name: Cetacaine

Cetacaine Liquid is used for:

Treating pain in certain areas (eg, mouth, throat, ears, vagina, rectum). It may also be used to numb these areas before medical procedures. It may also be used for other conditions as determined by your doctor.

Cetacaine Liquid in a local anesthetic. It works by numbing sensitive and painful areas.

Do NOT use Cetacaine Liquid if:

• you are allergic to any ingredient in Cetacaine Liquid or to other local anesthetics (eg, butacaine, procaine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cetacaine Liquid:

Some medical conditions may interact with Cetacaine Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if the skin at the application area is damaged or inflamed


• if you have an active illness or you have low levels of an enzyme called cholinesterase

Some MEDICINES MAY INTERACT with Cetacaine Liquid. Because little, if any, of Cetacaine Liquid is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Cetacaine Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cetacaine Liquid:

Use Cetacaine Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands before and after you use Cetacaine Liquid.


• To apply Cetacaine Liquid, carefully follow the instructions provided by your doctor. If you have any questions about how to use Cetacaine Liquid, check with your doctor.


• If you are using Cetacaine Liquid as a spray, do not spray for longer than 2 seconds. This may increase the risk of side effects.


• If you are applying Cetacaine Liquid with a cotton applicator, do not hold the cotton applicator in place for longer than directed. This may increase the risk of side effects.


• Do not apply Cetacaine Liquid under dentures. Do not cover the treated area with a cotton roll. This may increase the risk of side effects.


• If you are using Cetacaine Liquid on the mouth or throat, do not eat or drink for at least 1 hour after using Cetacaine Liquid.


• If you miss a dose of Cetacaine Liquid, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Cetacaine Liquid.

Important safety information:

• Do not get Cetacaine Liquid in your eyes. If you get it in your eyes, rinse at once with cool water.


• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor or dentist. Do not use more often than prescribed.


• Contact your doctor if you have persistent or worsening pain, redness, or irritation, or if you develop swelling, rash, or a fever. Tell your doctor if you have mouth sores that keep coming back.


• Cetacaine Liquid may cause harm if more than the amount used to treat pain is swallowed. If this occurs, contact your poison control center or emergency room right away.


• Use Cetacaine Liquid with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Cetacaine Liquid in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: It is not known if Cetacaine Liquid can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cetacaine Liquid while you are pregnant. It is not known if Cetacaine Liquid is found in breast milk. If you are or will be breast-feeding while you use Cetacaine Liquid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cetacaine Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue or purple color of the skin, lips, or nails; burning, irritation, redness, swelling, blisters, oozing, or tenderness at the application site.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1.800.FDA.1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Cetacaine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Cetacaine Liquid may cause harm if more than is used for pain is swallowed. Symptoms may include blue skin or lips; trouble breathing.

Proper storage of Cetacaine Liquid:

Store Cetacaine Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Cetacaine Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Cetacaine Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Cetacaine Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cetacaine Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cetacaine resources

• Cetacaine Side Effects (in more detail)
• Cetacaine Use in Pregnancy & Breastfeeding
• Cetacaine Support Group
• 0 Reviews · Be the first to review/rate this drug

Alomide

ALOMIDE 0.1% W/V

EYE DROPS, SOLUTION

(Lodoxamide)

Read all of this leaflet carefully before you start using this medicine.

• This medicine has been prescribed for you personally. You should not pass it on to other people. It may harm them, even if their symptoms are the same as yours.


• 
  Keep this leaflet. You may need to read it again. If you still have questions after reading it, please ask your doctor or your pharmacist.

The active substance is Lodoxamide 0.1% w/v (as lodoxamide trometamol).

Other ingredients: Benzalkonium chloride and disodium edetate which are included as a preservative, Mannitol, Hypromellose, Sodium citrate, Citric acid, Tyloxapol and Purified water. Hydrochloric acid and/or Sodium hydroxide may also be included in very small quantities to adjust the acidity or alkalinity of the product to ensure comfort of the product in the eye.

The Marketing Authorisation Holder for Alomide is

Alcon Laboratories (UK) Ltd.

Pentagon Park

Boundary Way

Hemel Hempstead

Herts

HP2 7UD

U.K.

The Manufacturer of Alomide is

Alcon-Couvreur NV

Rijksweg 14

B-2870 Puurs

Belgium

What Alomide Is And What It Is Used For.

The name of this medicine is Alomide. It contains lodoxamide, which is a substance that can be used to reduce redness, swelling, itching and irritation in the eye.

Alomide is available as a 10 ml solution in a DROP-TAINER bottle which has been specially designed for ease of use.

You have been prescribed this medicine to treat a non-infectious type of conjunctivitis, which has probably been caused by a substance to which your eyes are allergic. Conjunctivitis simply means an inflammation (redness, soreness or swelling) of the delicate membrane, the conjunctiva, which covers the inside of the eyelid and the front of the eye. Use of Alomide, as indicated by your doctor, will help to reduce the redness, swelling and irritation in your eye.

Before You Use Alomide.

In some circumstances this medicine may not be suitable for you and your doctor may wish to give you a different medicine. If your doctor is unaware that you have any of the following conditions please inform your doctor before starting to take this medicine.

• If you have ever had to stop taking a medicine because you were allergic to it.


• If you are pregnant or intending to become pregnant.


• If you are breast feeding a baby.

Alomide has not been shown to have any effects on any other medicines that you may also be taking, however, you should make sure your doctor knows what other medicines you are taking before using Alomide.

• You must not wear soft contact lenses whilst using this medicine.


• If your sight is affected in any way following the use of Alomide you should not drive or operate machinery.

How To Use Alomide.

Adults

The normal dosage is one or two drops into the affected eye four times a day at regular intervals. However, your doctor may change these instructions to suit your particular condition. Your own dosage instructions will be specified on the label attached to the outer carton of your medicine. If they are not, or you are not sure, then ask your doctor or pharmacist. It is important that you use Alomide as instructed by your doctor and that you do not use more than the recommended dose.

The signs and symptoms of your condition (redness, itching) may improve soon after using Alomide. Once this improvement occurs it is very important that you continue to use Alomide as indicated above, for as long as recommended by your doctor, to prevent the symptoms returning.

Children

Alomide is not recommended for children under the age of 4 years. For children aged 4 years and older the dosage is the same as that for adults.

What you should do if you miss a dose.

• It is important that Alomide is used at regular intervals, however, if you miss a dose DO NOT WORRY - just take the next dose when it is due.

What you should do if you take too much.

• If you take too much of this medicine it can be washed out of your eye with warm water.


• If you accidentally swallow this medicine consult your doctor immediately.

How to put the drops in your eye.

By following the 10 steps listed below you will ensure that Alomide is being used correctly and to the best effect.

• 1. Wash your hands before using Alomide.


• 2. Sit down in front of a mirror so that you can see what you are doing.


• 3. Shake the bottle well and then remove the cap from the bottle.


• 4. Make sure the dropper tip does not touch anything as this may contaminate the contents.


• 5. Hold the bottle upside down in one hand between your thumb and middle finger.


• 6. Using the forefinger of your other hand gently pull down the lower eyelid of the affected eye.


• 7. Place the dropper bottle tip close to, but not touching, your eye and gently tap the base of the bottle with your forefinger so that one or two drops fall into the gap between the eye and the lower lid.


• 8. Now release the lower eyelid, and blink a few times to make sure the whole of the eye is covered by the liquid.


• 9. Repeat steps 5 to 8, above, for the other eye, if necessary.


• 10. Replace and tightly close the cap on the dropper bottle.

Alomide Side Effects

• Because your eyes are already inflamed and sore you may experience some discomfort when you place Alomide into your eye. This discomfort may feel like one of the following:
  
  • burning, stinging, itching, increased tear production


• Other eye effects, which have been occasionally reported in 1-5% of patients, include the following:
  
  • itching of the eye, crusting of the eyelid, blurred vision, dry eye, watering


• Eye effects, which have occurred in less than 1% of patients include :
  
  • A feeling of something in your eye, discharge, inflammation of the eye or eyelid, tired eyes, feeling of warmth in the eye, dim vision, scratching of the eye surface and allergy.


• You may also experience reactions in other areas of your body including:
  
  • A feeling of warmth or flushing, dizziness, headaches, nausea, stomach discomfort, sleepiness, dry nose, sneezing and rash.


• If you experience any of the reactions listed above or any others not listed, after using Alomide then tell your doctor and follow his advice.

Storing Alomide.

• Keep Alomide in a safe place out of the reach and sight of children.


• Do not store above 25°C. Store upright.


• Keep the container tightly closed.

How long can I keep Alomide for?

• If the bottle has not been opened then you can keep Alomide until the expiry date shown as "EXP" on the bottle and carton label, providing it has been stored as described above.


• Do not use this medicine after the expiry date.


• Once the bottle has been opened then Alomide must be discarded one month after first opening.

Date of leaflet revision - 16th July 2001

PL 0649/0117

PA 290/63/1

Further information

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything then you should ask your doctor or the pharmacist.

Isdinium Rectal

Isdinium Rectal may be available in the countries listed below.

Ingredient matches for Isdinium Rectal

Hydrocortisone

Hydrocortisone is reported as an ingredient of Isdinium Rectal in the following countries:

• Spain

International Drug Name Search

Lamotrigine 5 mg dispersible / chewable tablets

1. Name Of The Medicinal Product

Lamotrigine 5 mg dispersible/ chewable tablets

2. Qualitative And Quantitative Composition

Each Lamotrigine 5 mg dispersible/ chewable tablet contains 5 mg lamotrigine.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Dispersible/ chewable tablet

White to off-white, capsule shaped uncoated tablets debossed with 'H' on one side and '81' on other side.

4. Clinical Particulars

4.1 Therapeutic Indications

Epilepsy:

Adults and adolescents aged 13 years and above

• Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including tonic-clonic seizures.

• Seizures associated with Lennox-Gastaut syndrome. Lamotrigine is given as adjunctive therapy but may be the initial antiepileptic drug (AED) to start with in Lennox-Gastaut syndrome.

Children and adolescents aged 2 to 12 years

• Adjunctive treatment of partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome.

• Monotherapy of typical absence seizures.

Bipolar disorder:

Adults aged 18 years and above

• Prevention of depressive episodes in patients with bipolar I disorder who experience predominantly depressive episodes (see section 5.1).

Lamotrigine is not indicated for the acute treatment of manic or depressive episodes.

4.2 Posology And Method Of Administration

Lamotrigine dispersible/ chewable tablets may be chewed, dispersed in a small volume of water (at least enough to cover the whole tablet) or swallowed whole with a little water.

If the calculated dose of lamotrigine (for example for treatment of children with epilepsy or patients with hepatic impairment) does not equate to whole tablets, the dose to be administered is that equal to the lower number of whole tablets.

Restarting therapy

Prescribers should assess the need for escalation to maintenance dose when restarting Lamotrigine in patients who have discontinued Lamotrigine for any reason, since the risk of serious rash is associated with high initial doses and exceeding the recommended dose escalation for lamotrigine (see section 4.4). The greater the interval of time since the previous dose, the more consideration should be given to escalation to the maintenance dose. When the interval since discontinuing lamotrigine exceeds five half-lives (see section 5.2), Lamotrigine should generally be escalated to the maintenance dose according to the appropriate schedule.

It is recommended that Lamotrigine not be restarted in patients who have discontinued due to rash associated with prior treatment with lamotrigine unless the potential benefit clearly outweighs the risk.

Epilepsy

The recommended dose escalation and maintenance doses for adults and adolescents aged 13 years and above (Table 1) and for children and adolescents aged 2 to 12 years (Table 2) are given below. Because of a risk of rash the initial dose and subsequent dose escalation should not be exceeded (see section 4.4).

When concomitant AEDs are withdrawn or other AEDs/medicinal products are added on to treatment regimes containing lamotrigine, consideration should be given to the effect this may have on lamotrigine pharmacokinetics (see section 4.5).

Table 1: Adults and adolescents aged 13 years and above - recommended treatment regimen in epilepsy

Treatment regimen	Weeks 1+2	Weeks 3+4	Usual maintenance dose
Monotherapy:	25 mg/day (once a day)	50 mg/day (once a day)	100-200 mg/day (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 50-100 mg every one to two weeks until optimal response is achieved. 500 mg/day has been required by some patients to achieve desired response.
Adjunctive therapy WITH valproate (inhibitor of lamotrigine glucuronidation – see section 4.5):
This dosage regimen should be used with valproate regardless of any concomitant medicinal products	12.5 mg/day (given as 25 mg on alternate days)	25 mg/day (once a day)	100-200 mg/day (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 25-50 mg every one to two weeks until optimal response is achieved
Adjunctive therapy WITHOUT valproate and WITH inducers of lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used without valproate but with: phenytoin carbamazepine phenobarbitone primidone rifampicin lopinavir/ritonavir	50 mg/day (once a day)	100 mg/day (two divided doses)	200-400 mg/day (two divided doses) To achieve maintenance, doses may be increased by maximum of 100 mg every one to two weeks until optimal response is achieved 700 mg/day has been required by some patients to achieve desired response
Adjunctive therapy WITHOUT valproate and WITHOUT inducers of lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used with other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation	25 mg/day (once a day)	50 mg/day (once a day)	100-200 mg/day (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 50-100 mg every one to two weeks until optimal response is achieved
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the treatment regimen as recommended for lamotrigine with concurrent valproate should be used.

Table 2: Children and adolescents aged 2 to 12 years - recommended treatment regimen in epilepsy (total daily dose in mg/kg body weight/day)

Treatment regimen	Weeks 1+2	Weeks 3+4	Usual maintenance dose
Monotherapy of typical absence seizures:	0.3 mg/kg/day (once a day or two divided doses)	0.6 mg/kg/day (once a day or two divided doses)	1-10 mg/kg/day, although some patients have required higher doses (up to 15 mg/kg/day) to achieve desired response (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 0.6 mg/kg/day every one to two weeks until optimal response is achieved
Adjunctive therapy WITH valproate (inhibitor of lamotrigine glucuronidation – see section 4.5):
This dosage regimen should be used with valproate regardless of any other concomitant medicinal products	0.15 mg/kg/day* (once a day)	0.3 mg/kg/day (once a day)	1-5 mg/kg/day (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 0.3 mg/kg every one to two weeks until optimal response is achieved, with a maximum maintenance dose of 200 mg/day
Adjunctive therapy WITHOUT valproate and WITH inducers of lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used without valproate but with: phenytoin carbamazepine phenobarbitone primidone rifampicin lopinavir/ritonavir	0.6 mg/kg/day (two divided doses)	1.2 mg/kg/day (two divided doses)	5-15 mg/kg/day (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 1.2 mg/kg every one to two weeks until optimal response is achieved, with a maximum maintenance dose of 400 mg/day.
Adjunctive therapy WITHOUT valproate and WITHOUT inducers of lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used with other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation	0.3 mg/kg/day (once a day or two divided doses)	0.6 mg/kg/day (once a day or two divided doses)	1-10 mg/kg/day (once a day or two divided doses) To achieve maintenance, doses may be increased by maximum of 0.6 mg/kg every one to two weeks until optimal response is achieved, with a maximum of maintenance dose of 200 mg/day
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the treatment regimen as recommended for lamotrigine with concurrent valproate should be used.
If the calculated daily dose in patients taking valproate is 2.5 mg or more but less than 5 mg, then Lamotrigine 5 mg dispersible/chewable tablets may be taken on alternate days for the first two weeks. If the calculated daily dose in patients taking valproate is less than 2.5 mg, then Lamotrigine should not be administered

To ensure a therapeutic dose is maintained the weight of a child must be monitored and the dose reviewed as weight changes occur. It is likely that patients aged two to six years will require a maintenance dose at the higher end of the recommended range.

If epileptic control is achieved with adjunctive treatment, concomitant AEDs may be withdrawn and patients continued on Lamotrigine monotherapy.

It should be noted that with the currently available Lamotrigine 5 mg dispersible/ chewable tablet strength, it is not possible to accurately initiate lamotrigine therapy using the recommended dosing guidelines in paediatric patients weighing less than 17 kg.

Children below 2 years

There are limited data on the efficacy and safety of lamotrigine for adjunctive therapy of partial seizures in children aged 1 month to 2 years (see section 4.4). There are no data in children below 1 month of age. Thus Lamotrigine is not recommended for use in children below 2 years of age. If, based on clinical need, a decision to treat is nevertheless taken, see sections 4.4, 5.1 and 5.2.

Bipolar disorder

The recommended dose escalation and maintenance doses for adults of 18 years of age and above are given in the tables below. The transition regimen involves escalating the dose of lamotrigine to a maintenance stabilisation dose over six weeks (Table 3) after which other psychotropic medicinal products and/or AEDs can be withdrawn, if clinically indicated (Table 4). The dose adjustments following addition of other psychotropic medicinal products and/or AEDs are also provided below (Table 5). Because of the risk of rash the initial dose and subsequent dose escalation should not be exceeded (see section 4.4).

Table 3: Adults aged 18 years and above – recommended dose escalation to the maintenance total daily stabilisation dose in treatment of bipolar disorder

Treatment Regimen	Weeks 1+ 2	Weeks 3 + 4	Week 5	Target Stabilisation Dose (Week 6)*
Monotherapy with lamotrigine OR adjunctive therapy WITHOUT valproate and WITHOUT inducers of lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used with other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation	25 mg/day (once a day)	50 mg/day (once a day or two divided doses)	100 mg/day (once a day or two divided doses)	200 mg/day – usual target dose for optimal response (once a day or two divided doses). Doses in the range 100 – 400 mg/day used in clinical trials
Adjunctive therapy WITH valproate (inhibitor of lamotrigine glucuronidation – see section 4.5):
This dosage regimen should be used with valproate regardless of any concomitant medicinal products	12.5 mg/day (given as 25 mg on alternate days)	25 mg/day (once a day)	50 mg/day (once a day or two divided doses)	100 mg/day – usual target dose for optimal response (once day or two divided doses) Maximum dose of 200 mg/day can be used depending on clinical response
Adjunctive therapy WITHOUT valproate and WITH inducers of lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used without valproate but with: phenytoin carbamazepine phenobarbitone primidone rifampicin lopinavir/ritonavir	50 mg/day (once a day)	100 mg/day (two divided doses)	200 mg/day (two divided doses)	300 mg/day in week 6, if necessary increasing to usual target dose of 400 mg/day in week 7, to achieve optimal response (two divided doses)
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the dose escalation as recommended for lamotrigine with concurrent valproate should be used.

* The Target stabilisation dose will alter depending on clinical response.

Table 4: Adults aged 18 years and above – maintenance stabilisation total daily dose following withdrawal of concomitant medicinal products in treatment of bipolar disorder

Once the target daily maintenance stabilisation dose has been achieved, other medicinal products may be withdrawn as shown below.

Treatment Regimen	Current lamotrigine stabilisation dose (prior to withdrawal)	Week 1 (beginning with withdrawal)	Week 2	Week 3 onwards*
Withdrawal of valproate (inhibitor of lamotrigine glucuronidation – see section 4.5), depending on original dose of lamotrigine:
When valproate is withdrawn, double the stabilisation dose, not exceeding an increase of more than 100 mg/week	100 mg/day	200 mg/day	Maintain this dose (200 mg/day) (two divided doses)
200 mg/day	300 mg/day	400 mg/day	Maintain this dose (400 mg/day)
Withdrawal of inducers of lamotrigine glucuronidation (see section 4.5), depending on original dose of lamotrigine:
This dosage regimen should be used when the following are withdrawn: phenytoin carbamazepine phenobarbitone primidone rifampicin lopinavir/ritonavir	400 mg/day	400 mg/day	300 mg/day	200 mg/day
300 mg/day	300 mg/day	225 mg/day	150 mg/day
200 mg/day	200 mg/day	150 mg/day	100 mg/day
Withdrawal of medicinal products that do NOT significantly inhibit or induce lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used when other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation are withdrawn	Maintain target dose achieved in dose escalation (200 mg/day; two divided doses) (dose range 100 – 400 mg/day)
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the treatment regimen recommended for lamotrigine is to initially maintain the current dose and adjust the lamotrigine treatment based on clinical response.
* Dose may be increased to 400 mg/day as needed.

Table 5: Adults aged 18 years and above - adjustment of lamotrigine daily dosing following the addition of other medicinal products in treatment of bipolar disorder

There is no clinical experience in adjusting the lamotrigine daily dose following the addition of other medicinal products. However, based on interaction studies with other medicinal products, the following recommendations can be made:

Treatment Regimen	Current lamotrigine stabilisation dose (prior to addition)	Week 1 (beginning with addition)	Week 2	Week 3 onwards
Addition of valproate (inhibitor of lamotrigine glucuronidation – see section 4.5), depending on original dose of lamotrigine:
This dosage regimen should be used when valproate is added regardless of any concomitant medicinal products	200 mg/day	100 mg/day	Maintain this dose (100 mg/day)
300 mg/day	150 mg/day	Maintain this dose (150 mg/day)
400 mg/day	200 mg/day	Maintain this dose (200 mg/day)
Addition of inducers of lamotrigine glucuronidation in patients NOT taking valproate (see section 4.5), depending on original dose of lamotrigine:
This dosage regimen should be used when the following are added without valproate: phenytoin carbamazepine phenobarbitone primidone rifampicin lopinavir/ritonavir	200 mg/day	200 mg/day	300 mg/day	400 mg/day
150 mg/day	150 mg/day	225 mg/day	300 mg/day
100 mg/day	100 mg/day	150 mg/day	200 mg/day
Addition of medicinal products that do NOT significantly inhibit or induce lamotrigine glucuronidation (see section 4.5):
This dosage regimen should be used when other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation are added	Maintain target dose achieved in dose escalation (200 mg/day; dose range 100 – 400 mg/day)
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the treatment regimen as recommended for lamotrigine with concurrent valproate should be used.

Discontinuation of Lamotrigine in patients with bipolar disorder

In clinical trials, there was no increase in the incidence, severity or type of adverse reactions following abrupt termination of lamotrigine versus placebo. Therefore, patients may terminate Lamotrigine without a step-wise reduction of dose.

Children and adolescents below 18 years

Lamotrigine is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy (see section 4.4).

General dosing recommendations for Lamotrigine in special patient populations

Women taking hormonal contraceptives

The use of an ethinyloestradiol/levonorgestrel (30 µg/150 µg) combination increases the clearance of lamotrigine by approximately two-fold, resulting in decreased lamotrigine levels. Following titration, higher maintenance doses of lamotrigine (by as much as two-fold) may be needed to attain a maximal therapeutic response. During the pill-free week, a two-fold increase in lamotrigine levels has been observed. Dose-related adverse events cannot be excluded. Therefore, consideration should be given to using contraception without a pill-free week, as first-line therapy (for example, continuous hormonal contraceptives or non-hormonal methods; see sections 4.4 and 4.5).

Starting hormonal contraceptives in patients already taking maintenance doses of lamotrigine and NOT taking inducers of lamotrigine glucuronidation

The maintenance dose of lamotrigine will in most cases need to be increased by as much as two-fold (see sections 4.4 and 4.5). It is recommended that from the time that the hormonal contraceptive is started, the lamotrigine dose is increased by 50 to 100 mg/day every week, according to the individual clinical response. Dose increases should not exceed this rate, unless the clinical response supports larger increases. Measurement of serum lamotrigine concentrations before and after starting hormonal contraceptives may be considered, as confirmation that the baseline concentration of lamotrigine is being maintained. If necessary, the dose should be adapted. In women taking a hormonal contraceptive that includes one week of inactive treatment ("pill-free week"), serum lamotrigine level monitoring should be conducted during week 3 of active treatment, i.e. on days 15 to 21 of the pill cycle. Therefore, consideration should be given to using contraception without a pill-free week, as first-line therapy (for example, continuous hormonal contraceptives or non-hormonal methods; see sections 4.4 and 4.5).

Stopping hormonal contraceptives in patients already taking maintenance doses of lamotrigine and NOT taking inducers of lamotrigine glucuronidation

The maintenance dose of lamotrigine will in most cases need to be decreased by as much as 50% (see sections 4.4 and 4.5). It is recommended to gradually decrease the daily dose of lamotrigine by 50- 100 mg each week (at a rate not exceeding 25% of the total daily dose per week) over a period of 3 weeks, unless the clinical response indicates otherwise. Measurement of serum lamotrigine concentrations before and after stopping hormonal contraceptives may be considered, as confirmation that the baseline concentration of lamotrigine is being maintained. In women who wish to stop taking a hormonal contraceptive that includes one week of inactive treatment ("pill-free week"), serum lamotrigine level monitoring should be conducted during week 3 of active treatment, i.e. on days 15 to 21 of the pill cycle. Samples for assessment of lamotrigine levels after permanently stopping the contraceptive pill should not be collected during the first week after stopping the pill.

Starting lamotrigine in patients already taking hormonal contraceptives

Dose escalation should follow the normal dose recommendation described in the tables.

Starting and stopping hormonal contraceptives in patients already taking maintenance doses of lamotrigine and TAKING inducers of lamotrigine glucuronidation

Adjustment to the recommended maintenance dose of lamotrigine may not be required.

Use with atazanavir/ritonavir

No adjustments to the recommended dose escalation of lamotrigine should be necessary when lamotrigine is added to the existing atazanavir/ritonavir therapy.

In patients already taking maintenance doses of lamotrigine and not taking glucuronidation inducers, the lamotrigine dose may need to be increased if atazanavir/ritonavir is added, or decreased if atazanavir/ritonavir is discontinued. Plasma lamotrigine monitoring should be conducted before and during 2 weeks after starting or stopping atazanavir/ritonavir, in order to see if lamotrigine dose adjustment is needed (see section 4.5).

Use with lopinavir/ritonavir

No adjustments to the recommended dose escalation of lamotrigine should be necessary when lamotrigine is added to the existing lopinavir/ritonavir therapy.

In patients already taking maintenance doses of lamotrigine and not taking glucuronidation inducers, the lamotrigine dose may need to be increased if lopinavir/ritonavir is added, or decreased if lopinavir/ritonavir is discontinued. Plasma lamotrigine monitoring should be conducted before and during 2 weeks after starting or stopping lopinavir/ritonavir, in order to see if lamotrigine dose adjustment is needed (see section 4.5).

Elderly (above 65 years):

No dosage adjustment from the recommended schedule is required. The pharmacokinetics of lamotrigine in this age group do not differ significantly from a non-elderly adult population (see section 5.2).

Renal impairment

Caution should be exercised when administering lamotrigine to patients with renal failure. For patients with end-stage renal failure, initial doses of lamotrigine should be based on patients´ concomitant medicinal products; reduced maintenance doses may be effective for patients with significant renal functional impairment (see sections 4.4 and 5.2).

Hepatic impairment

Initial, escalation and maintenance doses should generally be reduced by approximately 50% in patients with moderate (Child-Pugh grade B) and 75% in severe (Child-Pugh grade C) hepatic impairment. Escalation and maintenance doses should be adjusted according to clinical response (see section 5.2).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Skin rash

There have been reports of adverse skin reactions, which have generally occurred within the first eight weeks after initiation of lamotrigine treatment. The majority of rashes are mild and self-limiting, however serious rashes requiring hospitalisation and discontinuation of lamotrigine have also been reported. These have included potentially life threatening rashes such as Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.8).

In adults enrolled in studies utilizing the current lamotrigine dosing recommendations the incidence of serious skin rashes is approximately 1 in 500 in epilepsy patients. Approximately half of these cases have been reported as Stevens–Johnson syndrome (1 in 1000). In clinical trials in patients with bipolar disorder, the incidence of serious rash is approximately 1 in 1000.

The risk of serious skin rashes in children is higher than in adults. Available data from a number of studies suggest the incidence of rashes associated with hospitalisation in epileptic children is from 1 in 300 to 1 in 100.

In children, the initial presentation of a rash can be mistaken for an infection, physicians should consider the possibility of a reaction to lamotrigine treatment in children that develop symptoms of rash and fever during the first eight weeks of therapy.

Additionally the overall risk of rash appears to be strongly associated with:

• high initial doses of lamotrigine and exceeding the recommended dose escalation of lamotrigine therapy (see section 4.2)

• concomitant use of valproate (see section 4.2).

Caution is also required when treating patients with a history of allergy or rash to other AEDs as the frequency of non-serious rash after treatment with lamotrigine was approximately three times higher in these patients than in those without such history.

All patients (adults and children) who develop a rash should be promptly evaluated and lamotrigine withdrawn immediately unless the rash is clearly not related to lamotrigine treatment. It is recommended that lamotrigine not be restarted in patients who have discontinued due to rash associated with prior treatment with lamotrigine unless the potential benefit clearly outweighs the risk.

Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms including fever, lymphadenopathy, facial oedema and abnormalities of the blood and liver (see section 4.8). The syndrome shows a wide spectrum of clinical severity and may, rarely, lead to disseminated intravascular coagulation and multiorgan failure. It is important to note that early manifestations of hypersensitivity (for example fever, lymphadenopathy) may be present even though rash is not evident. If such signs and symptoms are present the patient should be evaluated immediately and lamotrigine discontinued if an alternative aetiology cannot be established.

Clinical worsening and suicide risk

Suicidal ideation and behaviour have been reported in patients treated with AEDs in several indications. A meta-analysis of randomised placebo-controlled trials of AEDs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for lamotrigine.

Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.

In patients with bipolar disorder, worsening of depressive symptoms and/or the emergence of suicidality may occur whether or not they are taking medications for bipolar disorder, including lamotrigine. Therefore patients receiving lamotrigine for bipolar disorder should be closely monitored for clinical worsening (including development of new symptoms) and suicidality, especially at the beginning of a course of treatment, or at the time of dose changes. Certain patients, such as those with a history of suicidal behaviour or thoughts, young adults, and those patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment, may be at a greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients who experience clinical worsening (including development of new symptoms) and/or the emergence of suicidal ideation/behaviour, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

Hormonal contraceptives

Effects of hormonal contraceptives on lamotrigine efficacy

The use of an ethinyloestradiol/levonorgestrel (30 µg/150 µg) combination increases the clearance of lamotrigine by approximately two-fold resulting in decreased lamotrigine levels (see section 4.5). A decrease in lamotrigine levels has been associated with loss of seizure control. Following titration, higher maintenance doses of lamotrigine (by as much as two-fold) will be needed in most cases to attain a maximal therapeutic response. When stopping hormonal contraceptives, the clearance of lamotrigine may be halved. Increases in lamotrigine concentrations may be associated with dose-related adverse events. Patients should be monitored with respect to this.

In women not already taking an inducer of lamotrigine glucuronidation and taking a hormonal contraceptive that includes one week of inactive treatment (for example "pill-free week"), gradual transient increases in lamotrigine levels will occur during the week of inactive treatment (see section 4.2). Variations in lamotrigine levels of this order may be associated with adverse effects. Therefore, consideration should be given to using contraception without a pill-free week, as first-line therapy (for example, continuous hormonal contraceptives or non-hormonal methods).

The interaction between other oral contraceptive or HRT treatments and lamotrigine have not been studied, though they may similarly affect lamotrigine pharmacokinetic parameters.

Effects of lamotrigine on hormonal contraceptive efficacy:

An interaction study in 16 healthy volunteers has shown that when lamotrigine and a hormonal contraceptive (ethinyloestradiol/levonorgestrel combination) are administered in combination, there is a modest increase in levonorgestrel clearance and changes in serum FSH and LH (see section 4.5). The impact of these changes on ovarian ovulatory activity is unknown. However, the possibility of these changes resulting in decreased contraceptive efficacy in some patients taking hormonal preparations with lamotrigine cannot be excluded. Therefore, patients should be instructed to promptly report changes in their menstrual pattern, i.e. breakthrough bleeding.

Dihydrofolate reductase

Lamotrigine has a slight inhibitory effect on dihydrofolic acid reductase, hence there is a possibility of interference with folate metabolism during long-term therapy (see section 4.6). However, during prolonged human dosing, lamotrigine did not induce significant changes in the haemoglobin concentration, mean corpuscular volume, or serum or red blood cell folate concentrations up to 1 year or red blood cell folate concentrations for up to 5 years.

Axid Pulvules

Generic Name: nizatidine (ni ZA ti deen)

Brand Names: Axid, Axid AR, Axid Pulvules

What is Axid Pulvules (nizatidine)?

Nizatidine is in a group of drugs called histamine-2 blockers. Nizatidine works by decreasing the amount of acid the stomach produces.

Nizatidine is used to treat ulcers in the stomach and intestines. Nizatidine also treats heartburn and erosive esophagitis caused by gastroesophageal reflux disease (GERD), a condition in which acid backs up from the stomach into the esophagus.

Nizatidine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Axid Pulvules (nizatidine)?

You should not use this medication if you are allergic to nizatidine or similar medications such as ranitidine (Zantac), cimetidine (Tagamet), or famotidine (Pepcid).

Before taking nizatidine, tell your doctor if you have kidney or liver disease, or stomach cancer or other problems.

Avoid taking cimetidine (Tagamet), ranitidine (Zantac), or famotidine (Pepcid) while you are taking nizatidine, unless your doctor has told you to.

Nizatidine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Nizatidine may be only part of a complete program of treatment that also includes changes in diet or lifestyle habits. Follow your doctor's instructions very closely.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

What should I discuss with my healthcare provider before taking Axid Pulvules (nizatidine)?

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

You should not use this medication if you are allergic to nizatidine or similar medications such as ranitidine (Zantac), cimetidine (Tagamet), or famotidine (Pepcid).

To make sure you can safely take nizatidine, tell your doctor if you have any of these other conditions:

• kidney disease;


• liver disease; or


• 
  

  stomach cancer or other problems.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Nizatidine can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking this medication. Do not give this medication to a child younger than 12 years old without the advice of a doctor.

How should I take Axid Pulvules (nizatidine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Although most ulcers heal within 4 weeks of nizatidine treatment, it may take up to 8 to 12 weeks of using this medicine before your ulcer heals. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using nizatidine.

Nizatidine may be only part of a complete program of treatment that also includes changes in diet or lifestyle habits. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light. Throw away any unused nizatidine liquid that is older than 30 days.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include blurred vision, watery eyes, drooling, nausea, vomiting, or diarrhea.

What should I avoid' while taking Axid Pulvules (nizatidine)?

Nizatidine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It can increase the risk of damage to your stomach.

Avoid taking cimetidine (Tagamet), ranitidine (Zantac), or famotidine (Pepcid) while you are taking nizatidine, unless your doctor has told you to.

Axid Pulvules (nizatidine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using nizatidine and call your doctor at once if you have a serious side effect such as:

• 
  

  pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  
  


• 
  

  unusual bleeding, purple or red pinpoint spots under your skin;

  
  


• 
  

  skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

  
  


• 
  

  fever, confusion; or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  headache, dizziness;

  
  


• 
  

  mild rash;

  
  


• 
  

  diarrhea; or

  
  


• 
  

  runny or stuffy nose, sore throat, cough.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Axid Pulvules (nizatidine)?

Tell your doctor about all other medications you use, especially aspirin.

There may be other drugs that can interact with nizatidine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Axid Pulvules resources

• Axid Pulvules Side Effects (in more detail)
• Axid Pulvules Use in Pregnancy & Breastfeeding
• Drug Images
• Axid Pulvules Drug Interactions
• Axid Pulvules Support Group
• 0 Reviews for Axid Pulvules - Add your own review/rating

• Nizatidine Prescribing Information (FDA)


• Nizatidine Professional Patient Advice (Wolters Kluwer)


• Axid MedFacts Consumer Leaflet (Wolters Kluwer)


• Axid Monograph (AHFS DI)


• Axid Prescribing Information (FDA)


• Axid Consumer Overview


• Axid AR Prescribing Information (FDA)

Compare Axid Pulvules with other medications

• Duodenal Ulcer
• Duodenal Ulcer Prophylaxis
• Erosive Esophagitis
• GERD
• Indigestion
• Stomach Ulcer

Where can I get more information?

• Your pharmacist can provide more information about nizatidine.

See also: Axid Pulvules side effects (in more detail)

Feosol Caplet

Generic Name: carbonyl iron (car BAH nill I ern)

Brand Names: Elemental Iron, Feosol Caplet, Icar, Iron Chews

What is Feosol Caplet (carbonyl iron)?

Carbonyl iron is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood.

Carbonyl iron is used as a dietary supplement, and to prevent and to treat iron deficiencies and iron deficiency anemia.

Carbonyl iron may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Feosol Caplet (carbonyl iron)?

Keep this medication out of the reach of children. An accidental overdose of iron by a child can be fatal.

Carbonyl iron may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking carbonyl iron if you take any other prescription or over-the-counter medicines.

Who should not take Feosol Caplet (carbonyl iron)?

Do not take carbonyl iron if you have

• 
  

  hemochromatosis,

  
  


• 
  

  hemosiderosis, or

  
  


• 
  

  hemolytic anemia.

  
  

Carbonyl iron may be dangerous if you have any of the conditions listed above.

If you do not have an iron deficiency, talk to your doctor about the use of carbonyl iron. Generally, carbonyl iron should not be taken chronically by individuals with a normal iron balance.

Talk to your doctor before taking carbonyl iron if you are pregnant. Talk to your doctor before taking carbonyl iron if you are breast-feeding a baby.

How should I take Feosol Caplet (carbonyl iron)?

Take carbonyl iron exactly as directed by your doctor, or as directed on the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each tablet with a full glass of water. Take carbonyl iron on an empty stomach for best results. If stomach upset occurs, take carbonyl iron with food or following a meal.

Shake the suspension well before measuring a dose. To ensure that you get the correct dose, measure the liquid form of carbonyl iron with a dose measuring cup or spoon, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist where you can get one.

Carbonyl iron may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking carbonyl iron if you take any other prescription or over-the-counter medicines.

Store carbonyl iron at room temperature, away from moisture and heat. Keep this medication out of the reach of children. An accidental overdose of iron by a child can be fatal.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time to take next dose, skip the dose you missed and take the next regularly scheduled dose as directed. Do not take a double dose.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a carbonyl iron overdose include decreased energy; nausea; vomiting; abdominal pain; tarry stools; a weak, rapid pulse; fever; coma; seizures; and death.

What should I avoid while taking Feosol Caplet (carbonyl iron)?

Keep this medication out of the reach of children. An accidental overdose of iron by a child can be fatal.

Carbonyl iron may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking carbonyl iron if you take any other prescription or over-the-counter medicines.

Feosol Caplet (carbonyl iron) side effects

If you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives), stop taking carbonyl iron and seek emergency medical attention.

Other less serious side effects are more likely to occur. Continue taking carbonyl iron and talk to your doctor or pharmacist if you experience

• 
  

  stomach upset,

  
  


• 
  

  nausea or vomiting,

  
  


• 
  

  constipation,

  
  


• 
  

  diarrhea,

  
  


• 
  

  black or darker than normal appearing stools, or

  
  


• 
  

  temporary staining of the teeth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Feosol Caplet (carbonyl iron)?

Do not take carbonyl iron within 2 hours of a dose of any of the following medicines

• 
  

  a tetracycline antibiotic such as tetracycline (Achromycin, Sumycin), minocycline (Minocin, Dynacin), doxycycline (Vibramycin, Monodox), demeclocycline (Declomycin), oxytetracycline (Terramycin), or troleandomycin (TAO);

  
  


• 
  

  a fluoroquinolone antibiotic such as ciprofloxacin (Cipro), enoxacin (Penetrex) ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), grepafloxacin (Raxar), sparfloxacin (Zagam), or trovafloxacin (Trovan);

  
  


• 
  

  levodopa (Larodopa, Dopar, Sinemet);

  
  


• 
  

  levothyroxine (Synthroid, Levoxyl, others);

  
  


• 
  

  methyldopa (Aldomet); or

  
  


• 
  

  penicillamine (Cuprimine).

  
  

Carbonyl iron may decrease the absorption of the drugs listed above.

Do not take antacids within 2 hours of a dose of carbonyl iron. Antacids may decrease the absorption of carbonyl iron.

Drugs other than those listed here may also interact with carbonyl iron. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines while taking carbonyl iron.

More Feosol Caplet resources

• Feosol Caplet Side Effects (in more detail)
• Feosol Caplet Use in Pregnancy & Breastfeeding
• Drug Images
• Feosol Caplet Drug Interactions
• Feosol Caplet Support Group
• 0 Reviews for Feosol Caplet - Add your own review/rating

• Icar Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Iron Chews Prescribing Information (FDA)

Compare Feosol Caplet with other medications

• Iron Deficiency Anemia

Where can I get more information?

• Your pharmacist has additional information about carbonyl iron written for health professionals that you may read.

See also: Feosol Caplet side effects (in more detail)

Ethambutol Hydrochloride

Class: Antituberculosis Agents
VA Class: AM500
CAS Number: 1070-11-7
Brands: Myambutol

Introduction

Antituberculosis agent.^{103 106 a}

Uses for Ethambutol Hydrochloride

Tuberculosis

Treatment of active (clinical) tuberculosis (TB) in conjunction with other antituberculosis agents.^{103 c d e}

First-line agent for treatment of pulmonary TB; used in the initial intensive treatment phase.¹⁰⁶

First-line agent for management of drug-resistant pulmonary TB.¹⁰⁶

For initial treatment of active TB caused by drug-susceptible M. tuberculosis, recommended multiple-drug regimens consist of an initial intensive phase (2 months) and a continuation phase (4 or 7 months).^{106 109} Although the usual duration of treatment for drug-susceptible pulmonary and extrapulmonary TB (except disseminated infections and TB meningitis) is 6–9 months,^{106 109} ATS, CDC, and IDSA state that completion of treatment is determined more accurately by the total number of doses and should not be based solely on the duration of therapy.¹⁰⁶ A longer duration of treatment (e.g., 12–24 months) usually is necessary for infections caused by drug-resistant M. tuberculosis.^{106 109}

Patients with treatment failure or drug-resistant M. tuberculosis, including multidrug-resistant (MDR) TB (resistant to both isoniazid and rifampin) or extensively drug-resistant (XDR) TB (resistant to both isoniazid and rifampin and also resistant to a fluoroquinolone and at least one parenteral second-line antimycobacterial such as capreomycin, kanamycin, or amikacin), should be referred to or managed in consultation with experts in the treatment of TB as identified by local or state health departments or CDC.¹⁰⁶

Mycobacterium avium Complex (MAC) Infections

Treatment of M. avium complex (MAC) infections† in conjunction with other antimycobacterials, including infections in HIV-infected adults, adolescents, or children†.^{107 c d}

For initial treatment of nodular/bronchiectatic pulmonary disease caused by macrolide-susceptible MAC, ATS and IDSA recommend a 3-times weekly regimen of clarithromycin (or azithromycin), ethambutol, and rifampin in most patients.¹⁰⁷ For initial treatment of fibrocavitary or severe nodular/bronchiectatic pulmonary disease caused by macrolide-susceptible MAC, ATS and IDSA recommend a daily regimen of clarithromycin (or azithromycin), ethambutol, and rifampin (or rifabutin) and state that consideration can be given to adding amikacin or streptomycin during the first 2–3 months of treatment for extensive (especially fibrocavitary) disease or when previous therapy has failed.¹⁰⁷ Although a 2-drug regimen of clarithromycin (or azithromycin) and ethambutol may be adequate for treatment of nodular/bronchiectatic MAC disease in some patients, such regimens should not be used for fibrocavitary disease because of the risk of emergence of macrolide resistance.¹⁰⁷

For treatment of disseminated MAC disease, including in HIV-infected individuals, ATS, CDC, NIH, and IDSA recommend a regimen of clarithromycin (or azithromycin) and ethambutol with or without rifabutin.^{107 c d}

Treatment of MAC infections is complicated and should be directed by clinicians familiar with mycobacterial diseases; consultation with a specialist is particularly important when the patient cannot tolerate first-line drugs or when the infection has not responded to prior therapy or is caused by macrolide-resistant MAC.¹⁰⁷

Prevention of recurrence (secondary prophylaxis) of disseminated MAC infections† in HIV-infected adults, adolescents, and children†.^{108 c d} USPHS/IDSA, CDC, NIH, IDSA, and others recommend clarithromycin (or azithromycin) given with ethambutol (with or without rifabutin) for secondary prophylaxis after the initial infection has been treated.^{108 c}

Not used for primary prevention (primary prophylaxis) of disseminated MAC infection in HIV-infected individuals.¹⁰⁸ Drug of choice for primary prophylaxis is azithromycin or clarithromycin;^{107 108} rifabutin (with or without azithromycin) is an alternative.^{107 108}

Mycobacterium kansasii and Other Mycobacterial Infections

Treatment of M. kansasii† infections in conjunction with other antimycobacterials.^{107 g} ATS and IDSA recommend a regimen of isoniazid, rifampin, and ethambutol for treatment of pulmonary or disseminated infections caused by rifampin-susceptible M. kansasii.¹⁰⁷ If rifampin-resistant M. kansasii are involved, ATS and IDSA recommend a 3-drug regimen based on results of in vitro susceptibility, including clarithromycin (or azithromycin), moxifloxacin, ethambutol, sulfamethoxazole, or streptomycin.¹⁰⁷

Treatment of M. marinum† infections in conjunction with other antimycobacterials (e.g., clarithromycin and/or rifampin).^{107 i j l} Optimum regimens not identified.^{107 i j l} Monotherapy (minocycline, clarithromycin, doxycycline, co-trimoxazole) may be effective for superficial cutaneous infections,^j but a multiple-drug regimen usually used for severe cutaneous infections or infections in immunocompromised individuals.^{i j}

Treatment of M. xenopi† infections in conjunction with other antimycobacterials.¹⁰⁷ Optimum regimens not established; in vivo response may not correlate with in vitro susceptibility.¹⁰⁷ ATS and IDSA state that a regimen of clarithromycin, rifampin, and ethambutol generally has been used, although rate of relapse is high.¹⁰⁷ A regimen of isoniazid, rifampin (or rifabutin), ethambutol, and clarithromycin (with or without streptomycin during initial treatment) also has been suggested.¹⁰⁷

Ethambutol Hydrochloride Dosage and Administration

Administration

Oral Administration

Administer orally without regard to meals.^{103 e}

Dosage

Available as ethambutol hydrochloride; dosage expressed in terms of the salt.^{103 e}

Must be used in conjunction with other antimycobacterial agents for treatment of active (clinical) TB,^{103 108 e} treatment or prevention of MAC infections†,^{107 108 c} or treatment of other mycobacterial infections†.¹⁰⁷

Can be used in daily or intermittent (e.g., 2 or 3 times weekly) multiple-drug TB regimens.^{106 109 c d}

Pediatric Patients

Tuberculosis

Treatment of Active (Clinical) Tuberculosis in Children†

Oral

Children <15 years of age or weighing ≤40 kg†: 15–25 mg/kg once daily recommended by ATS, CDC, IDSA, AAP, and others.^{106 109 d h} If an intermittent regimen is used, 50 mg/kg twice weekly.^{106 109 d h} ATS, CDC, and IDSA recommend that children receive a maximum of 1 g per dose;^{106 d} AAP and others recommend a maximum of 2.5 g per dose.^{109 h}

Treatment of Active (Clinical) Tuberculosis in Adolescents

Oral

Adolescents ≥15 years of age weighing 40–55 kg: 800 mg daily, 2 g twice weekly, or 1.2 g 3 times weekly recommended by ATS, CDC, and IDSA.¹⁰⁶

Adolescents ≥15 years of age weighing 56–75 kg: 1.2 g daily, 2.8 g twice weekly, or 2 g 3 times weekly recommended by ATS, CDC, and IDSA.¹⁰⁶

Adolescents ≥15 years of age weighing 76-90 kg: 1.6 g daily, 4 g twice weekly, or 2.4 g 3 times weekly recommended by ATS, CDC, and IDSA.¹⁰⁶

Adolescents: AAP and others recommend 15–25 mg/kg (up to 2.5 g) once daily or 50 mg/kg twice weekly (up to 2.5 g per dose).^{109 h}

Mycobacterium avium Complex (MAC) Infections†

Treatment of Disseminated MAC in HIV-infected Children†

Oral

15–25 mg/kg (up to 1 g) once daily.^{d h} Used in conjunction with clarithromycin (7.5–15 mg/kg [up to 500 mg] twice daily) or azithromycin (10–12 mg/kg [up to 500 mg] once daily) with or without rifabutin (10–20 mg/kg [up to 300 mg] once daily).^d

Treatment of Disseminated MAC in HIV-infected Adolescents†

Oral

15 mg/kg once daily in conjunction with either clarithromycin (500 mg twice daily) or azithromycin (500 mg once daily) with or without rifabutin (300 mg once daily).^{107 c}

Prevention of MAC Recurrence (Secondary Prophylaxis) in HIV-infected Children†

Oral

15 mg/kg (up to 900 mg) once daily.^{108 h} Used in conjunction with clarithromycin (7.5 mg/kg [up to 500 mg] twice daily) or azithromycin (5 mg/kg [up to 250 mg] once daily) with or without rifabutin (5 mg/kg [up to 300 mg] once daily).¹⁰⁸

Secondary prophylaxis to prevent MAC recurrence in HIV-infected children usually continued for life.¹⁰⁸ The safety of discontinuing secondary MAC prophylaxis in children whose CD4⁺ T-cell count increases in response to antiretroviral therapy has not been studied.¹⁰⁸

Prevention of MAC Recurrence (Secondary Prophylaxis) in HIV-infected Adolescents†

Oral

15 mg/kg (up to 900 mg) once daily.^{108 c h} Used in conjunction with either clarithromycin (500 mg twice daily) or azithromycin (500 mg once daily) with or without rifabutin (300 mg once daily).^{108 c}

Secondary prophylaxis to prevent MAC recurrence usually continued for life in HIV-infected adolescents.^{108 c}

Consideration can be given to discontinuing such prophylaxis after ≥12 months in those who remain asymptomatic with respect to MAC and have an increase in CD4⁺ T-cell count to >100/mm³ that has been sustained for ≥6 months.^{108 c} Reinitiate prophylaxis if CD4⁺ T-cell count decreases to <100/mm³.^{108 c}

Adults

Tuberculosis

Treatment of Active (Clinical) Tuberculosis

Oral

Manufacturers recommend 15 mg/kg once daily in previously untreated adults.^{103 e} In previously treated adults, manufacturers recommend 25 mg/kg once daily for 60 days, followed by 15 mg/kg once daily.^{103 e}

Adults weighing 40–55 kg: 800 mg once daily, 2 g twice weekly, or 1.2 g 3 times weekly recommended by ATS, CDC, and IDSA.^{106 c}

Adults weighing 56–75 kg: 1.2 g once daily, 2.8 g twice weekly, or 2 g 3 times weekly recommended by ATS, CDC, and IDSA.^{106 c}

Adults weighing 76-90 kg: 1.6 g once daily, 4 g twice weekly, or 2.4 g 3 times weekly recommended by ATS, CDC, and IDSA.^{106 c}

Mycobacterium avium Complex (MAC) Infections†

Initial Treatment of Pulmonary MAC Infections (Nodular/bronchiectatic Disease) Caused by Macrolide-susceptible Strains†

Oral

25 mg/kg 3 times weekly in conjunction with rifampin (600 mg 3 times weekly) and either clarithromycin (1 g 3 times weekly) or azithromycin (500 mg 3 times weekly) recommended by ATS and IDSA.¹⁰⁷ Continue until patient has been culture negative on treatment for 1 year.¹⁰⁷

Intermittent (3-times weekly) regimen is not recommended for those with cavitary or moderate or severe disease or those who have been previously treated.¹⁰⁷

Initial Treatment of Pulmonary MAC Infections (Fibrocavitary or Severe Nodular/bronchiectatic Disease) Caused by Macrolide-susceptible Strains†

Oral

15 mg/kg once daily in conjunction with either rifampin (10 mg/kg [up to 600 mg] once daily) or rifabutin (150–300 mg once daily) and either clarithromycin (0.5–1 g daily) or azithromycin (250 mg once daily) recommended by ATS and IDSA.¹⁰⁷ Continue until patient has been culture negative on treatment for 1 year.¹⁰⁷ Consideration can be given to including amikacin or streptomycin 3-times weekly during the first 2–3 months of treatment for extensive, especially fibrocavitary, disease or when previous therapy has failed.¹⁰⁷

Treatment of Disseminated MAC in HIV-infected and Other Adults†

Oral

15 mg/kg once daily in conjunction with either clarithromycin (500 mg twice daily) or azithromycin (500 mg once daily) with or without rifabutin (300 mg once daily) recommended by ATS, CDC, and IDSA.^{107 c}

Prevention of MAC Recurrence (Secondary Prophylaxis) in HIV-infected Adults†

Oral

15 mg/kg once daily.^{108 c} Used in conjunction with either clarithromycin (500 mg twice daily) or azithromycin (500 mg once daily) with or without rifabutin (300 mg once daily).^{108 c}

Secondary prophylaxis to prevent MAC recurrence usually continued for life in HIV-infected adults.¹⁰⁸

Consideration can be given to discontinuing such prophylaxis after ≥12 months in those who remain asymptomatic with respect to MAC and have an increase in CD4⁺ T-cell count to >100/mm³ that has been sustained for ≥6 months.^{108 c} Reinitiate prophylaxis if CD4⁺ T-cell count decreases to <100/mm³.^{108 c}

Mycobacterium kansasii and Other Mycobacterial Infections†

Treatment of Pulmonary or Disseminated Infections Caused by Rifampin-susceptible M. kansasii†

Oral

15 mg/kg once daily in conjunction with rifampin (10 mg/kg [up to 600 mg] daily), isoniazid (5 mg/kg [up to 300 mg] daily), and pyridoxine (50 mg daily) recommended by ATS and IDSA.¹⁰⁷

Continue until patient has been culture negative on treatment for 1 year.¹⁰⁷ A longer duration may be needed in HIV-infected individuals with disseminated infections.¹⁰⁷

Treatment of M. marinum Infections†

Oral

15–25 mg/kg daily in conjunction with rifampin (600 mg daily) and/or clarithromycin.^{107 i j l}

Optimal duration of treatment not known; continue for 3–6 months or until at least 1–2 months after resolution of symptoms.^{107 i j l}

Prescribing Limits

Pediatric Patients

Tuberculosis

Treatment of Active (Clinical) Tuberculosis in Children†

Oral

Maximum 1 g per dose recommended by ATS, CDC, and IDSA for once-daily or twice-weekly regimens;^{106 d} maximum 2.5 g per dose recommended by AAP and others for once-daily or twice-weekly regimens.^{109 h}

Mycobacterium avium Complex (MAC) Infections in Children†

Oral

Maximum 1 g once daily for treatment of disseminated MAC infections.^d Maximum 900 mg once daily for prevention of MAC recurrence (secondary prophylaxis).¹⁰⁸

Special Populations

Renal Impairment

Reduce dosage based on degree of renal impairment and serum concentrations of the drug.^{103 106 c e h}

Some experts recommend 15 mg/kg once every 24–36 hours in adults with Cl_cr 10–50 mL/minute, 15 mg/kg once every 48 hours in those with Cl_cr <10 mL/minute, and 15 mg/kg 3 times weekly (after hemodialysis) in those undergoing hemodialysis.^c Others recommend 15–20 mg/kg 3 times weekly (after dialysis) in adults with end-state renal disease (Cl_cr <30 mL/minute, on hemodialysis).¹⁰⁶

In children with renal impairment, some experts recommend that the usual dose be given once every 24 hours in those with Cl_cr >50 mL/minute or once every 24–36 hours in those with Cl_cr 10–50 mL/minute.^h In children with Cl_cr <10 mL/minute, these experts recommend that a decreased dose be given once every 48 hours.^h Supplemental doses are recommended after hemodialysis.^h

Cautions for Ethambutol Hydrochloride

Contraindications

• 
  

  Known hypersensitivity to ethambutol or any ingredient in the formulation.^{103 e}

  
  


• 
  

  Optic neuritis, unless clinical judgment deems it necessary to use the drug.^{103 e}

  
  


• 
  

  Patients unable to appreciate and report visual adverse effects or changes in vision (e.g., young children, unconscious patients).¹⁰³ (See Pediatric Use under Cautions.)

  
  

Warnings/Precautions

Warnings

Ocular Effects

Decreased visual acuity, constriction of visual fields, central and peripheral scotomas, and loss of red-green color discrimination reported.^{103 106 a e} May be due to optic neuritis, but has occurred in the absence of a diagnosis of optic or retrobulbar neuritis.^{103 e} May be related to dose and duration of treatment.^{103 106 e}

Perform ophthalmic evaluation (ophthalmoscopy, finger perimetry, test for color discrimination) at baseline and periodically during treatment.^{103 106 e} Test each eye separately and together since change in visual acuity may be unilateral or bilateral.^{103 e} Evaluate monthly in patients receiving >15 mg/kg daily, in those receiving the drug for >2 months, and in those with renal impairment.^{103 106 e}

Use with caution in patients with ocular defects (e.g., cataracts, recurrent ocular inflammatory conditions, optic neuritis, diabetic retinopathy) that make visual changes difficult to detect or evaluate; weigh benefits versus possible visual deterioration in these patients.^{103 e}

Discontinue if substantial changes in visual acuity occur.^{103 e} Changes in visual acuity usually reversible (over several weeks or months), but irreversible blindness has been reported.^{103 e}

Hepatic Effects

Liver toxicities, including fatalities, have been reported.¹⁰³

Perform baseline and periodic assessment of hepatic function.^{103 e}

Sensitivity Reactions

Anaphylactoid reactions, dermatitis, pruritus reported.¹⁰³

General Precautions

Precautions Related to Treatment of Tuberculosis

Should not be used alone for the treatment of active TB; must be given in conjunction with other antituberculosis agents.¹⁰⁶

Clinical specimens for microscopic examination and mycobacterial cultures and in vitro susceptibility testing should be obtained prior to initiation of antituberculosis therapy and periodically during treatment to monitor therapeutic response.¹⁰⁶ The antituberculosis regimen should be modified as needed.¹⁰⁶ Patients with positive cultures after 4 months of treatment should be considered to have failed treatment (usually as the result of noncompliance or drug-resistant TB).¹⁰⁶

Compliance with the full course of antituberculosis therapy and all drugs included in the multiple-drug regimen is critical.¹⁰⁶ Missed doses increase the risk of treatment failure and increase the risk that M. tuberculosis will develop resistance to the antituberculosis regimen.¹⁰⁶

To ensure compliance, ATS, CDC, IDSA, and AAP recommend that directly observed (supervised) therapy (DOT) be used for treatment of active (clinical) TB whenever possible, especially when intermittent regimens are used, when the patient is immunocompromised or infected with HIV, or when drug-resistant M. tuberculosis is involved.^{106 109 c d}

Laboratory Monitoring

Assess organ system function (e.g., renal, hepatic, hematopoietic) at baseline and periodically during treatment.^{103 e}

Specific Populations

Pregnancy

Category C.¹⁰³

Ophthalmic abnormalities have been reported in infants born to women who received antituberculosis regimens that included ethambutol during pregnancy.¹⁰³

The ATS, CDC, IDSA, AAP and others consider ethambutol safe for use in pregnant women;^{106 108 109} AAP states potential benefits outweigh the risks to the infant.¹⁰⁹

Lactation

Distributed into milk; use only if possible benefits outweigh potential risks.¹⁰³

AAP considers ethambutol compatible with breast-feeding.^b

Pediatric Use

Safety not established in children <13 years of age; manufacturers do not recommend use in this age group.^{103 e} Has been used in pediatric patients without unusual adverse effects.^d

ATS, CDC, IDSA, and AAP state that ethambutol can be used safety in older children, but should be used with caution in children in whom it may be difficult to monitor visual acuity (e.g., <5 years of age).^{106 109} If used in pediatric patients, perform ophthalmic evaluations once monthly during treatment.^d

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity in this age group cannot be ruled out.¹⁰³

Hepatic Impairment

ATS, CDC, and IDSA state that ethambutol can be used safely in patients with hepatic disease.¹⁰⁶

Renal Impairment

Use with caution; dosage reduction based on serum concentrations is advised.^{103 e} Closely monitor visual acuity and color discrimination (i.e., monthly).^{103 106} (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Ophthalmic effects (decreased visual acuity, scotoma, color blindness, visual defect), joint pain, GI effects (anorexia, nausea, vomiting, GI upset, abdominal pain), fever, malaise, headache, dizziness, mental confusion.^{103 e}

Interactions for Ethambutol Hydrochloride

Specific Drugs

Drug	Interaction	Comments
Antacids	Aluminum-containing antacids: Decreased ethambutol serum concentrations and urinary excretion; possible decreased oral absorption of the antimycobacterial103	Administer aluminum-containing antacids ≥4 hours after ethambutol103
Rifabutin	Pharmacokinetic interaction unlikelyf

Ethambutol Hydrochloride Pharmacokinetics

Absorption

Bioavailability

75–80% of an oral dose is absorbed from the GI tract;^a peak plasma concentrations achieved within 2–4 hours.^{103 e}

Food

Food does not appear to affect absorption.^{103 e}

Special Populations

Serum concentrations are higher in patients with renal impairment.^a

Distribution

Extent

Widely distributed into most body tissues and fluids.^a Highest concentrations are found in erythrocytes, kidneys, lungs, and saliva; lower drug concentrations are found in ascitic fluid, pleural fluid, brain, and CSF.^a

Crosses the placenta and is distributed into cord blood and amniotic fluid.¹⁰⁰

Distributed into milk.¹⁰³

Plasma Protein Binding

8–22%.^a

Elimination

Metabolism

Undergoes oxidation in the liver to an aldehyde intermediate which is converted to a dicarboxylic acid derivative.^{103 e}

Elimination Route

Excreted in urine as unchanged drug (50%) and metabolites (8–15%) and in feces as unchanged drug (20–22%).^{103 e}

Removed by peritoneal dialysis and to a lesser extent by hemodialysis.^a

Half-life

3.3 hours.^a

Special Populations

Half-life prolonged in patients with impaired renal or hepatic function.^a Half-life may be ≥7 hours in patients with renal failure.^a

Stability

Storage

Oral

Tablets

15–30°C^e or 20–25°C¹⁰³ , depending on the manufacturer. Protect from light and moisture.^e

Actions and SpectrumActions

• 
  

  Bacteriostatic in action.^a

  
  


• 
  

  Appears to inhibit the synthesis of one or more metabolites in susceptible bacteria resulting in impairment of cellular metabolism, arrest of multiplication, and cell death.^{103 e}

  
  


• 
  

  A highly specific agent; active only against Mycobacterium.^{103 a} Active against M. tuberculosis,^a M. avium complex (MAC),^a M. bovis,^a M. kansasii,^{107 a g} and some strains of M. fortuitum.^a Although M. marinum may be susceptible,^{107 a} resistance has been reported.^k Active in vitro against M. gordonae,¹⁰⁷ M. malmoense,¹⁰⁷ and M. smegmatis.¹⁰⁷ Has limited activity against M. genavense.¹⁰⁷ M. haemophilum¹⁰⁷ and some strains of M. xenopi are resistant.¹⁰⁷

  
  


• 
  

  Natural and acquired resistance to ethambutol demonstrated in vitro and in vivo in strains of M. tuberculosis.^{103 a}

  
  


• 
  

  No evidence of cross-resistance with other currently available antimycobacterials.^{103 e}

  
  

Advice to Patients

• 
  

  Advise patients that poor compliance with antituberculosis regimens can result in treatment failure and development of drug-resistant TB, which can be life-threatening and lead to other serious health risks.¹⁰⁶

  
  


• 
  

  Importance of completing full course of therapy; importance of not missing any doses.¹⁰³

  
  


• 
  

  Importance of promptly informing clinicians of any change in visual acuity.^{103 e}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹⁰³

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹⁰³

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹⁰³ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Ethambutol Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	100 mg	Ethambutol Tablets	VersaPharm
			Myambutol	X-Gen
		400 mg	Ethambutol Tablets	Barr, VersaPharm
			Myambutol (scored)	X-Gen

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Ethambutol HCl 400MG Tablets (VERSAPHARM): 30/$55.99 or 90/$153.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

100. Holdiness MR. Transplacental pharmacokinetics of the antituberculosis drugs. Clin Pharmacokinet. 1987; 13:125-9. [IDIS 233465] [PubMed 3304771]

102. Brock PG, Roach M. Antituberculosis drugs during pregnancy. Lancet. 1981; 1:102.

103. X-Gen. Myambutol (ethambutol hydrochloride) tablets USP prescribing information. Northport, NY; 2004 Jun.

104. Gulliford M, Mackay AD, Prowse K. Cholestatic jaundice caused by ethambutol. BMJ. 1986; 292:866. [IDIS 213885] [PubMed 3083914]

105. US Centers for Disease Control and Prevention. Initial therapy for tuberculosis in the era of multidrug resistance. Recommendations of the Advisory Council for the Elimination of Tuberculosis. MMWR Recomm Rep. 1993; 42(RR-7):1-8.

106. Centers for Disease Control and Prevention. Treatment of tuberculosis, American Thoracic Society, CDC, and Infectious Diseases Society of America. MMWR Recomm Rep. 2003; 52(No. RR-11):1-77.

107. Griffith DE, Aksamit T, Brown-Elliott BA et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007; 175:367-416. [PubMed 17277290]

108. US Public Health Service (USPHS) and Infectious Diseases Society of America (IDSA) Prevention of Opportunistic Infections Working Group. 2001 USPHS/IDSA guidelines for the prevention of opportunistic infections in persons with human immunodeficiency virus. From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website ()

109. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.

a. AHFS drug information 2007. McEvoy GK. Ethambutol. Bethesda, MD. American Society of Health-System Pharmacists;2007:550-2.

b. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Philadelphia; PA: Lippincott Wiliams & Wilkins; 2002:509-10.

c. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-15):1-112.

d. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-exposed and infected children: recommendations from CDC, the National Institutes of Health, and the Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-14):1-92.

e. VersaPharm. Ethambutol hydrochloride tablets USP prescribing information. Marietta, GA; 2001 Feb.

f. Pfizer. Mycobutin (rifabutin) capsules USP prescribing information. New York, NY; 2006 Feb.

g. Shitrit D, Baum GL, Priess R et al. Pulmonary Mycobacterium kansasii infection in Israel, 1999-2004: clinical features, drug susceptibility, and outcome. Chest. 2006; 129:771-6. [PubMed 16537880]

h. Robertson J, Shilkofski N, eds. The Harriet Lane handbook: a manual for pediatric house officers. 17th ed. Philadelphia, PA: Elsevier Mosby: 2005:808-9,1058.

i. Lewis FM, Marsh BJ, von Reyn CF. Fish tank exposure and cutaneous infections due to Mycobacterium marinum: tuberculin skin testing, treatment, and prevention. Clin Infect Dis. 2003; 37:390-7. [PubMed 12884164]

j. Rallis E, Koumantaki-Mathioudaki E. Treatment of Mycobacterium marinum cutaneous infections. Exp Opin Pharmacother. 2007; 8:2965-78.

k. Aubry A, Jarlier V, Escolano S et al. Antibiotic susceptibility pattern of Mycobacterium marinum. Antimicrob Agents Chemother. 2000; 44:3133-6. [PubMed 11036036]

l. Edelstein H. Mycobacterium marinum skin infections. Report of 31 cases and review of the literature. Arch Intern Med. 1994; 154:1359-64. [PubMed 8002687]

More Ethambutol Hydrochloride resources

• Ethambutol Hydrochloride Side Effects (in more detail)
• Ethambutol Hydrochloride Dosage
• Ethambutol Hydrochloride Use in Pregnancy & Breastfeeding
• Drug Images
• Ethambutol Hydrochloride Drug Interactions
• Ethambutol Hydrochloride Support Group
• 0 Reviews for Ethambutol Hydrochloride - Add your own review/rating

• Ethambutol Prescribing Information (FDA)


• ethambutol Concise Consumer Information (Cerner Multum)


• ethambutol Advanced Consumer (Micromedex) - Includes Dosage Information


• Ethambutol MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Ethambutol Hydrochloride with other medications

• Mycobacterium avium-intracellulare, Prophylaxis
• Mycobacterium avium-intracellulare, Treatment
• Tuberculosis, Active