Veletri

epoprostenol sodium

Dosage Form: injection, powder, lyophilized, for solution
FULL PRESCRIBING INFORMATION

Indications and Usage for Veletri

Veletri is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases.

Veletri Dosage and Administration

Important Note: Reconstitute Veletri only as directed with Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not dilute reconstituted solutions of Veletri or administer it with other parenteral solutions or medications [see Warnings and Precautions (5.1)].

Dosage

Prepare continuous chronic infusion of Veletri as directed, and administer through a central venous catheter. Temporary peripheral intravenous infusion may be used until central access is established. Initiate chronic infusion of Veletri at 2 ng/kg/min and increase in increments of 2 ng/kg/min every 15 minutes or longer until a tolerance limit to the drug is established or further increases in the infusion rate are not clinically warranted. If dose-limiting pharmacologic effects occur, then decrease the infusion rate until Veletri is tolerated. In clinical trials, the most common dose-limiting adverse events were nausea, vomiting, hypotension, sepsis, headache, abdominal pain, or respiratory disorder (most treatment-limiting adverse events were not serious). If the initial infusion rate of 2 ng/kg/min is not tolerated, use a lower dose.

In the controlled 12-week trial in PAH/SSD, for example, the dose increased from a mean starting dose of 2.2 ng/kg/min. During the first 7 days of treatment, the dose was increased daily to a mean dose of 4.1 ng/kg/min on day 7 of treatment. At the end of week 12, the mean dose was 11.2 ng/kg/min. The mean incremental increase was 2 to 3 ng/kg/min every 3 weeks.

Dosage Adjustments

Base changes in the chronic infusion rate on persistence, recurrence, or worsening of the patient's symptoms of pulmonary hypertension and the occurrence of adverse events due to excessive doses of Veletri. In general, expect increases in dose from the initial chronic dose.

Consider increments in dose if symptoms of pulmonary hypertension persist or recur. Adjust the infusion by 1- to 2-ng/kg/min increments at intervals sufficient to allow assessment of clinical response; these intervals should be at least 15 minutes. In clinical trials, incremental increases in dose occurred at intervals of 24 to 48 hours or longer. Following establishment of a new chronic infusion rate, observe the patient, and monitor standing and supine blood pressure and heart rate for several hours to ensure that the new dose is tolerated.

During chronic infusion, the occurrence of dose-limiting pharmacological events may necessitate a decrease in infusion rate, but the adverse event may occasionally resolve without dosage adjustment. Make dosage decreases gradually in 2-ng/kg/min decrements every 15 minutes or longer until the dose-limiting effects resolve. Avoid abrupt withdrawal of Veletri or sudden large reductions in infusion rates. Except in life-threatening situations (e.g., unconsciousness, collapse, etc.), infusion rates of Veletri should be adjusted only under the direction of a physician.

In patients receiving lung transplants, doses of epoprostenol were tapered after the initiation of cardiopulmonary bypass.

Administration

Veletri, once prepared as directed [see Reconstitution (2.4)], is administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump. During initiation of treatment, Veletri may be administered peripherally.

The ambulatory infusion pump used to administer Veletri should: (1) be small and lightweight, (2) be able to adjust infusion rates in 2-ng/kg/min increments, (3) have occlusion, end-of-infusion, and low-battery alarms, (4) be accurate to ±6% of the programmed rate, and (5) be positive pressure-driven (continuous or pulsatile) with intervals between pulses not exceeding 3 minutes at infusion rates used to deliver Veletri. The reservoir should be made of polyvinyl chloride, polypropylene, or glass. The infusion pump used in the most recent clinical trials was the CADD-1 HFX 5100 (SIMS Deltec). A 60-inch microbore non-DEHP extension set with proximal antisyphon valve, low priming volume (0.9 mL), and in-line 0.22 micron filter was used during clinical trials.

To avoid potential interruptions in drug delivery, the patient should have access to a backup infusion pump and intravenous infusion sets. Consider a multi-lumen catheter if other intravenous therapies are routinely administered.

Reconstitution

Veletri is stable only when reconstituted as directed using Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not reconstitute or mix Veletri with any other parenteral medications or solutions prior to or during administration. Each vial is for single use only; discard any unused solution.

Use after storage of the reconstituted solution

Prior to use, Veletri solutions reconstituted with 5 mL diluent must be protected from light and can be refrigerated at 2° to 8°C (36° to 46°F) for as long as 5 days or held at up to 25°C (77°F) for up to 48 hours prior to use. Do not freeze reconstituted solutions of Veletri. Discard any reconstituted solution that has been frozen. Discard any reconstituted solution if it has been refrigerated for more than 5 days, or if held at room temperature for more than 48 hours.

Before administration, reconstituted solutions are further diluted to the final concentration.

During use, a single reservoir of diluted solution of 15000 ng/mL or above of Veletri prepared as directed can be administered at room temperature for up to 24 hours. (If lower concentrations are chosen, pump reservoirs should be changed every 12 hours when administered at room temperature.) Do not expose this solution to direct sunlight.

Use after reconstitution and immediate dilution to final concentration

Veletri solution reconstituted with 5 mL of Sterile Water for Injection, USP or Sodium Chloride 0.9% Injection, and immediately diluted to the final concentration in the drug delivery reservoir can be administered per the conditions of use as outlined in Table 1.

Table 1: Maximum duration of administration (hours) at room temperature (25°C/ 77°F) of fully diluted solutions in the drug delivery reservoir

Final concentration range	Immediate administration	If stored at 2° to 8°C (36° to 46°F) for 1 day	If stored at 2° to 8°C (36° to 46°F) for 7 days
≥3,000 ng/mL and <6,000 ng/mL	12 hours	"Do not use"	"Do not use"
≥ 6,000 ng/mL and < 9,000 ng/mL	24 hours	12 hours	"Do not use"
≥ 9,000 ng/mL and < 12,000 ng/mL	24 hours	12 hours	12 hours
≥12,000 ng/mL and < 30,000 ng/mL	24 hours	24 hours	12 hours
≥30,000 ng/mL	72 hours	48 hours	24 hours

Do not expose this solution to direct sunlight.

A concentration for the solution of Veletri should be selected that is compatible with the infusion pump being used with respect to minimum and maximum flow rates, reservoir capacity, and the infusion pump criteria listed above. Veletri, when administered chronically, should be prepared in a drug delivery reservoir appropriate for the infusion pump. Outlined in Table 2 are directions for preparing different concentrations of Veletri for up to a 72-hour period. Each vial is for single use only; discard any unused solution.

Table 2: Reconstitution and Dilution Instructions

To make 100 mL of solution with Final Concentration (ng/mL) of:	Directions:
* Higher concentrations may be prepared for patients who receive Veletri long-term.
3,000 ng/ml	Dissolve contents of one 1.5 mg vial with 5 mL of Sterile Water for Injection, USP or Sodium Chloride 0.9% Injection, USP. Withdraw 1 mL of the vial contents and add to a sufficient volume of the identical diluent to make a total of 100 mL.
6,000 ng/mL	Dissolve contents of one 1.5 mg vial with 5 mL of Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Withdraw 2 mL of the vial contents and add to a sufficient volume of the identical diluent to make a total of 100 mL.
9,000 ng/ml	Dissolve contents of one 1.5 mg vial with 5 mL of Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Withdraw 3 mL of the vial contents and add to a sufficient volume of the identical diluent to make a total of 100 mL.
12,000 ng/ml	Dissolve contents of one 1.5 mg vial with 5 mL of Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Withdraw 4 mL of the vial contents and add to a sufficient volume of the identical diluent to make a total of 100 mL.
15,000 ng/mL*	Dissolve contents of one 1.5 mg vial with 5 mL of Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Withdraw entire vial contents and add to a sufficient volume of the identical diluent to make a total of 100 mL.
30,000 ng/mL*	Dissolve contents of two 1.5 mg vials each with 5 mL of Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Withdraw entire vial contents and add to a sufficient volume of the identical diluent to make a total of 100 mL.

Infusion rates may be calculated using the following formula:

Infusion Rate (mL/hr) =	[Dose (ng/kg/min) × Weight (kg) × 60 min/hr]
	Final Concentration (ng/mL)

Tables 3 to 8 provide infusion delivery rates for doses up to 16 ng/kg/min based upon patient weight, drug delivery rate, and concentration of the solution of Veletri to be used. These tables may be used to select the most appropriate concentration of Veletri that will result in an infusion rate between the minimum and maximum flow rates of the infusion pump and that will allow the desired duration of infusion from a given reservoir volume. For infusion/dose rates lower than those listed in Tables 3 to 8, it is recommended that the pump rate be set by a healthcare professional such that steady state is achieved in the patient, keeping in mind the half life of epoprostenol is no more than six minutes. Higher infusion rates, and therefore, more concentrated solutions may be necessary with long-term administration of Veletri.

Table 3: Infusion Rates for Veletri at a Concentration of 3,000 ng/mL

	Dose or Drug Delivery Rate (ng/kg/min)
Patient weight (kg)	2	3	4	5
	Infusion Delivery Rate (mL/hr)
20	---	1.2	1.6	2.0
30	1.2	1.8	2.4	3.0
40	1.6	2.4	3.2	4.0
50	2.0	3.0	4.0
60	2.4	3.6
70	2.8
80	3.2
90	3.6
100	4.0

Table 4: Infusion Rates for Veletri at a Concentration of 6,000 ng/mL

	Dose or Drug Delivery Rate (ng/kg/min)
Patient weight (kg)	2	3	4	5
	Infusion Delivery Rate (mL/hr)
20	---	---	---	---
30	---	---	1.2	1.5
40	---	1.2	1.6	2.0
50	1.0	1.5	2.0	2.5
60	1.2	1.8	2.4	3.0
70	1.4	2.1	2.8	3.5
80	1.6	2.4	3.2	4.0
90	1.8	2.7	3.6
100	2.0	3.0	4.0

Table 5: Infusion Rates for Veletri at a Concentration of 9,000 ng/mL

	Dose or Drug Delivery Rate (ng/kg/min)
Patient weight (kg)	3	6	9
	Infusion Delivery Rate (mL/hr)
20	---	---	---
30	---	1.2	1.8
40	---	1.6	2.4
50	1.0	2.0	3.0
60	1.2	2.4	3.6
70	1.4	2.8
80	1.6	3.2
90	1.8	3.6
100	2.0	4.0

Table 6: Infusion Rates for Veletri at a Concentration of 12,000 ng/mL

	Dose or Drug Delivery Rate (ng/kg/min)
Patient weight (kg)	4	6	8	10
	Infusion Delivery Rate (mL/hr)
20	---	---	---	---
30	---	---	1.2	1.5
40	---	1.2	1.6	2.0
50	1.0	1.5	2.0	2.5
60	1.2	1.8	2.4	3.0
70	1.4	2.1	2.8	3.5
80	1.6	2.4	3.2	4.0
90	1.8	2.7	3.6
100	2.0	3.0	4.0

Table 7: Infusion Rates for Veletri at a Concentration of 15,000 ng/mL

	Dose or Drug Delivery Rate (ng/kg/min)
Patient weight (kg)	4	6	8	10	12	14	16
	Infusion Delivery Rate (mL/hr)
20	---	---	---	---	1.0	1.1	1.3
30	---	---	1.0	1.2	1.4	1.7	1.9
40	---	1.0	1.3	1.6	1.9	2.2	2.6
50	---	1.2	1.6	2.0	2.4	2.8	3.2
60	1.0	1.4	1.9	2.4	2.9	3.4	3.8
70	1.1	1.7	2.2	2.8	3.4	3.9
80	1.3	1.9	2.6	3.2	3.8
90	1.4	2.2	2.9	3.6
100	1.6	2.4	3.2	4.0

Table 8: Infusion Rates for Veletri at a Concentration of 30,000 ng/mL

	Dose or Drug Delivery Rate (ng/kg/min)
Patient weight (kg)	6	8	10	12	14	16
30	---	---	---	---	---	1.0
40	---	---	---	1.0	1.1	1.3
50	---	---	1.0	1.2	1.4	1.6
60	---	1.0	1.2	1.4	1.7	1.9
70	---	1.1	1.4	1.7	2.0	2.2
80	1.0	1.3	1.6	1.9	2.2	2.6
90	1.1	1.4	1.8	2.2	2.5	2.9
100	1.2	1.6	2.0	2.4	2.8	3.2

Dosage Forms and Strengths

Veletri contains epoprostenol sodium equivalent to 1.5 mg (1,500,000 ng) epoprostenol and is supplied as a sterile lyophilized material in a 10 mL vial with a red flip-off seal.

Contraindications

A large study evaluating the effect of epoprostenol on survival in NYHA Class III and IV patients with congestive heart failure due to severe left ventricular systolic dysfunction was terminated after an interim analysis of 471 patients revealed a higher mortality in patients receiving epoprostenol plus conventional therapy than in those receiving conventional therapy alone. The chronic use of Veletri in patients with congestive heart failure due to severe left ventricular systolic dysfunction is therefore contraindicated.

Some patients with pulmonary hypertension have developed pulmonary edema during dose initiation, which may be associated with pulmonary veno-occlusive disease. Veletri should not be used chronically in patients who develop pulmonary edema during dose initiation.

Veletri is also contraindicated in patients with known hypersensitivity to the drug or to structurally related compounds.

Warnings and Precautions

General

Reconstitute Veletri only as directed using Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not mix Veletri with any other parenteral medications or solutions prior to or during administration.

Veletri should be used only by clinicians experienced in the diagnosis and treatment of pulmonary hypertension. Carefully establish the diagnosis of idiopathic or heritable PAH or PAH/CTD.

Dose Initiation

Veletri is a potent pulmonary and systemic vasodilator. Initiate Veletri in a setting with adequate personnel and equipment for physiologic monitoring and emergency care. Dose initiation has been performed during right heart catheterization and without cardiac catheterization. During dose initiation, asymptomatic increases in pulmonary artery pressure coincident with increases in cardiac output occurred rarely. In such cases, consider dose reduction, but such an increase does not imply that chronic treatment is contraindicated.

Chronic Use and Dose Adjustment

During chronic use, deliver Veletri continuously on an ambulatory basis through a permanent indwelling central venous catheter. Unless contraindicated, administer anticoagulant therapy to patients receiving Veletri to reduce the risk of pulmonary thromboembolism or systemic embolism through a patent foramen ovale. To reduce the risk of infection, use aseptic technique in the reconstitution and administration of Veletri and in routine catheter care. Because epoprostenol is metabolized rapidly, even brief interruptions in the delivery of Veletri may result in symptoms associated with rebound pulmonary hypertension including dyspnea, dizziness, and asthenia. Intravenous therapy with Veletri will likely be needed for prolonged periods, possibly years, so consider the patient's capacity to accept and care for a permanent intravenous catheter and infusion pump.

Based on clinical trials, the acute hemodynamic response (reduction in pulmonary artery resistance) to epoprostenol did not correlate well with improvement in exercise tolerance or survival during chronic use of epoprostenol. Adjust dosage of Veletri during chronic use at the first sign of recurrence or worsening of symptoms attributable to pulmonary hypertension or the occurrence of adverse events associated with epoprostenol [see Dosage and Administration (2)]. Following dosage adjustments, monitor standing and supine blood pressure and heart rate closely for several hours.

Withdrawal Effects

Abrupt withdrawal (including interruptions in drug delivery) or sudden large reductions in dosage of Veletri may result in symptoms associated with rebound pulmonary hypertension, including dyspnea, dizziness, and asthenia. In clinical trials, one Class III primary pulmonary hypertension patient's death was judged attributable to the interruption of epoprostenol. Avoid abrupt withdrawal.

Sepsis

See Adverse Reactions (6.1)

Adverse Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

During clinical trials, adverse events were classified as follows: (1) adverse events during dose initiation and escalation, (2) adverse events during chronic dosing, and (3) adverse events associated with the drug delivery system.

Adverse Events during Dose Initiation and Escalation

During early clinical trials, epoprostenol was increased in 2-ng/kg/min increments until the patients developed symptomatic intolerance. The most common adverse events and the adverse events that limited further increases in dose were generally related to vasodilation, the major pharmacologic effect of epoprostenol. The most common dose-limiting adverse events (occurring in ≥1% of patients) were nausea, vomiting, headache, hypotension, and flushing, but also include chest pain, anxiety, dizziness, bradycardia, dyspnea, abdominal pain, musculoskeletal pain, and tachycardia. Table 9 lists the adverse events reported during dose initiation and escalation in decreasing order of frequency.

Table 9: Adverse Events during Dose Initiation and Escalation

Adverse Events Occurring in ≥1% of Patients	Epoprostenol (n = 391)
Flushing	58%
Headache	49%
Nausea/vomiting	32%
Hypotension	16%
Anxiety, nervousness, agitation	11%
Chest pain	11%
Dizziness	8%
Bradycardia	5%
Abdominal pain	5%
Musculoskeletal pain	3%
Dyspnea	2%
Back pain	2%
Sweating	1%
Dyspepsia	1%
Hypesthesia/paresthesia	1%
Tachycardia	1%

Adverse Events during Chronic Administration:

Interpretation of adverse events is complicated by the clinical features of PAH, which are similar to some of the pharmacologic effects of epoprostenol (e.g., dizziness, syncope). Adverse events which may be related to the underlying disease include dyspnea, fatigue, chest pain, edema, hypoxia, right ventricular failure, and pallor. Several adverse events, on the other hand, can clearly be attributed to epoprostenol. These include hypotension, bradycardia, tachycardia, pulmonary edema, bleeding at various sites, thrombocytopenia, headache, abdominal pain, pain (unspecified), sweating, rash, arthralgia, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms, anxiety/nervousness, and agitation. In addition, chest pain, fatigue, and pallor have been reported during epoprostenol therapy, and a role for the drug in these events cannot be excluded.

Adverse Events during Chronic Administration for Idiopathic or Heritable PAH:

In an effort to separate the adverse effects of the drug from the adverse effects of the underlying disease, Table 10 lists adverse events that occurred at a rate at least 10% greater on epoprostenol than on conventional therapy in controlled trials for idiopathic or heritable PAH.

Table 10: Adverse Events Regardless of Attribution Occurring in Patients with Idiopathic or Heritable PAH with ≥ 10% Difference between Epoprostenol and Conventional Therapy Alone

Adverse Event	Epoprostenol (n = 52)	Conventional Therapy (n = 54)
Occurrence More Common With Epoprostenol
General
Chills/fever/sepsis/flu-like symptoms	25%	11%
Cardiovascular
Tachycardia	35%	24%
Flushing	42%	2%
Gastrointestinal
Diarrhea	37%	6%
Nausea/vomiting	67%	48%
Musculoskeletal
Jaw pain	54%	0%
Myalgia	44%	31%
Nonspecific musculoskeletal pain	35%	15%
Neurological
Anxiety/nervousness/tremor	21%	9%
Dizziness	83%	70%
Headache	83%	33%
Hypesthesia, hyperesthesia, paresthesia	12%	2%

Thrombocytopenia has been reported during uncontrolled clinical trials in patients receiving epoprostenol.

Adverse Events during Chronic Administration for PAH/SSD

In an effort to separate the adverse effects of the drug from the adverse effects of the underlying disease, Table 11 lists adverse events that occurred at a rate at least 10% greater on epoprostenol in the controlled trial.

Table 11: Adverse Events Regardless of Attribution Occurring in Patients with PAH/SSD With ≥10% Difference Between Epoprostenol and Conventional Therapy Alone

Adverse Event	Epoprostenol (n = 56)	Conventional Therapy (n = 55)
Cardiovascular
Flushing	23%	0%
Hypotension	13%	0%
Gastrointestinal
Anorexia	66%	47%
Nausea/vomiting	41%	16%
Diarrhea	50%	5%
Musculoskeletal
Jaw pain	75%	0%
Pain/neck pain/arthralgia	84%	65%
Neurological
Headache	46%	5%
Skin and Appendages
Skin ulcer	39%	24%
Eczema/rash/urticaria	25%	4%

Although the relationship to epoprostenol administration has not been established, pulmonary embolism has been reported in several patients taking epoprostenol and there have been reports of hepatic failure.

Adverse Events Attributable to the Drug Delivery System

Chronic infusions of epoprostenol are delivered using a small, portable infusion pump through an indwelling central venous catheter. During controlled PAH trials of up to 12 weeks' duration, the local infection rate was about 18%, and the rate fo

Vistide

Generic Name: cidofovir (Intravenous route)

sye-DOF-oh-vir

Intravenous route(Solution)

Acute renal failure resulting in dialysis and/or contributing to death has been reported. Use intravenous prehydration with normal saline and administration of probenecid with each cidofovir infusion to reduce nephrotoxicity. Monitor renal function within 48 hours prior to each dose and adjust dose as appropriate. Cidofovir is contraindicated in patients who are receiving other nephrotoxic agents. Neutropenia has been observed; monitor neutrophil counts during therapy. Cidofovir was carcinogenic, teratogenic, and caused hypospermia in animal studies .

Commonly used brand name(s)

In the U.S.

• Vistide

Available Dosage Forms:

• Solution

Therapeutic Class: Antiviral

Chemical Class: Cytosine Nucleoside Analog

Uses For Vistide

Cidofovir is an antiviral. It is used to treat infections caused by viruses.

Cidofovir is used to treat the symptoms of cytomegalovirus (CMV) infection of the eyes (CMV retinitis) in patients with acquired immune deficiency syndrome (AIDS). Cidofovir will not cure this eye infection, but it may help to keep the symptoms from becoming worse.

This medicine is available only with your doctor's prescription.

Before Using Vistide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Cidofovir can cause serious side effects, including possible cancer and trouble in having children later. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of cidofovir in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amikacin


• Dibekacin


• Foscarnet


• Framycetin


• Gentamicin


• Kanamycin


• Neomycin


• Netilmicin


• Pentamidine


• Streptomycin


• Tobramycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—Cidofovir can cause harmful effects on the kidney

Proper Use of Vistide

To get the best results, cidofovir must be given for the full time of treatment. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, cidofovir must be given on a regular schedule.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For treatment of cytomegalovirus (CMV) retinitis:
    
    • Adults—Dose is based on body weight and must be determined by your doctor. At first, 5 milligrams (mg) per kilogram (kg) (2.3 mg per pound) of body weight is injected slowly into a vein once a week for two weeks in a row. Then the dose is reduced to 5 mg per kg (2.3 mg per pound) of body weight injected slowly into a vein once every two weeks. Probenecid is taken along with each dose of cidofovir; follow your doctor's instructions for how much and when to take probenecid.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Precautions While Using Vistide

It is very important that your doctor check you at regular visits for any blood problems that may be caused by this medicine.

It is very important that your ophthalmologist (eye doctor) check your eyes at regular visits since it is still possible that you may have some loss of eyesight during cidofovir treatment.

Vistide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Medicines like cidofovir can sometimes cause serious side effects such as blood problems and kidney problems; these are described below. Cidofovir has also been found to cause cancer in animals, and there is a chance it could cause cancer in humans as well. Discuss these possible side effects with your doctor.

Check with your doctor immediately if any of the following side effects occur:

More common

• Fever, chills, or sore throat

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Decreased urination


• increased thirst and urination

Rare

• Decreased vision or any change in vision

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea


• headache


• loss of appetite


• nausea


• vomiting

Less common

• Generalized weakness


• loss of strength

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Vistide side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Vistide resources

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

• Vistide Prescribing Information (FDA)


• Vistide MedFacts Consumer Leaflet (Wolters Kluwer)


• Vistide Concise Consumer Information (Cerner Multum)


• Vistide Monograph (AHFS DI)


• Cidofovir Professional Patient Advice (Wolters Kluwer)

Compare Vistide with other medications

• CMV Retinitis
• Smallpox Vaccine Reaction

Premarin Tablets

Pronunciation: KON-joo-gay-ted ES-troe-jenz
Generic Name: Conjugated Estrogens
Brand Name: Premarin

Premarin should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens may increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Premarin. Talk with your doctor if you have questions about the benefits and risks of using Premarin.

Premarin should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Premarin.

Premarin is used for:

Treating certain symptoms of menopause (eg, hot flashes, vaginal dryness or itching). It is used to prevent osteoporosis (weak bones) after menopause in certain patients. It is used in certain patients to treat low estrogen levels and prostate cancer and breast cancer. It may also be used for other conditions as determined by your doctor.

Premarin is a mixture of female estrogen hormones. It works by replacing natural estrogens in women who no longer produce enough estrogen. It works for advanced prostate cancer by blocking male hormones.

Do NOT use Premarin if:

• you are allergic to any ingredient in Premarin


• you have had a severe reaction (eg, swelling of the hands, face, lips, eyes, throat, or tongue; trouble swallowing or breathing; hoarseness) after taking Premarin


• you are pregnant or suspect you may be pregnant


• you have known or suspected breast cancer or another estrogen-dependent cancer, or you have a history of breast cancer


• you have a history of liver problems or liver disease


• you have abnormal vaginal bleeding of an unknown cause


• you have active blood clots (eg, of the legs or lungs), a risk of developing blood clots, or a history of blood clots


• you have had a stroke or heart attack

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

Before using Premarin:

Some medical conditions may interact with Premarin. 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 you have a condition called hereditary angioedema


• if you have a history of breast lumps, breast disease, or an abnormal mammogram, or if a member of your family has had breast cancer


• if you have a vaginal infection or a history of uterus problems (eg fibroids, endometriosis, abnormal vaginal bleeding, cancer), or you have had your uterus removed (hysterectomy)


• if you have a history of asthma, depression, diabetes, seizures, gallbladder disease, pancreatitis, heart problems, high blood cholesterol or triglyceride levels, high blood calcium levels, high blood pressure, low blood levels of parathyroid hormone, or porphyria


• if you have a history of kidney or liver problems, yellowing of the skin or eyes, cancer, lupus, migraines, or thyroid problems


• if you smoke, use tobacco, are very overweight, will be having surgery, or will be confined to a bed or chair for a period of time


• if a member of your family has had high cholesterol or triglyceride levels, blood clots (eg, in the leg or lung), or lupus, or has been very overweight

Some MEDICINES MAY INTERACT with Premarin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Hydantoins (eg, phenytoin) or rifamycins (eg, rifampin) because they may decrease Premarin's effectiveness


• Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Premarin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Premarin 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 Premarin:

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

• An extra patient leaflet is available with Premarin. Talk to your pharmacist if you have questions about this information.


• Take Premarin by mouth with or without food.


• Taking Premarin at the same time each day will help you remember to take it.


• If you miss a dose of Premarin, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Smoking while taking Premarin may increase your risk of blood clots (especially in women older than 35 years old).


• If you are only being treated for vaginal menopause symptoms, products applied locally, such as vaginal creams, tablets, or rings, should be considered before products taken by mouth or absorbed through the skin. If you have other medical conditions and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options.


• Non-drug therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.


• Diabetes patients - Premarin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Premarin may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.


• If you wear contact lenses and you develop problems with them, contact your doctor.


• If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor at least 4 to 6 weeks beforehand. You may need to stop taking Premarin or take other special precautions for a period of time.


• If you notice something that looks like a tablet in your stool, contact your doctor.


• Premarin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Premarin.


• Lab tests, including physical exams, cholesterol levels, and blood pressure, may be performed while you use Premarin. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Follow your doctor's instructions for examining your own breasts. Report any lumps immediately.


• Talk with your doctor regularly (eg, every 3 to 6 months) about whether you need to continue taking Premarin.


• Use Premarin with caution in ELDERLY women; they may be more sensitive to its effects.


• Use Premarin with caution in CHILDREN; they may need regular growth and/or development checks while they use Premarin.


• PREGNANCY and BREAST-FEEDING: Do not use Premarin if you are pregnant. If you think you may be pregnant, contact your doctor right away. Premarin is found in breast milk. If you are or will be breast-feeding while you use Premarin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Premarin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast pain or tenderness; gas; hair loss; headache; leg cramps; mild fluid retention; mild nausea or vomiting; nervousness; spotting or breakthrough bleeding; stomach cramps or bloating; weakness.

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; unusual hoarseness); abnormal vaginal bleeding; breast lumps or pain; calf pain, swelling, or tenderness; chest pain; confusion; coughing up blood; fainting; mental or mood changes (eg, depression); migraine headache; new or worsening memory problems; one-sided weakness; severe or persistent dizziness or headache; severe or persistent stomach pain or tenderness; shortness of breath; slurred speech; sudden, severe, or persistent vomiting; swelling of the hands or feet; symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); unusual vaginal discharge/itching/odor; vision loss or other vision changes; vomiting; weakness or numbness of an arm or leg.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Premarin 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. Symptoms may include abnormal vaginal bleeding; breast tenderness; drowsiness or fatigue; nausea and vomiting; stomach pain.

Proper storage of Premarin:

Store Premarin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Premarin out of the reach of children and away from pets.

General information:

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


• Premarin 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 Premarin. Additionally, your doctor may have prescribed Premarin for a use not mentioned above. 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 Premarin resources

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

Compare Premarin with other medications

• Abnormal Uterine Bleeding
• Atrophic Urethritis
• Atrophic Vaginitis
• Breast Cancer, Palliative
• Hypoestrogenism
• Oophorectomy
• Osteoporosis
• Postmenopausal Symptoms
• Primary Ovarian Failure
• Prostate Cancer

Urispas

Pronunciation: fla-VOX-ate
Generic Name: Flavoxate
Brand Name: Urispas

Urispas is used for:

Relieving pain, frequency, and urgency of urination as well as nighttime urination associated with certain medical conditions. It may be used in combination with other medicines to treat ulcers. It may also be used for other conditions as determined by your doctor.

Urispas is an anticholinergic. It works by decreasing muscle spasms of the bladder.

Do NOT use Urispas if:

• you are allergic to any ingredient in Urispas


• you have stomach bleeding, difficulty swallowing due to esophagus problems, urinary blockage, a bowel obstruction, or rectal bleeding

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

Before using Urispas:

Some medical conditions may interact with Urispas. 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 you have an enlarged prostate or urinary problems


• if you have glaucoma

Some MEDICINES MAY INTERACT with Urispas. However, no specific interactions with Urispas are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Urispas 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 Urispas:

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

• Urispas may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you miss a dose of Urispas, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Urispas may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Urispas. Using Urispas alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Urispas. Urispas will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• Do not become overheated in hot weather or during exercise or other activities; heatstroke may occur.


• Urispas may cause your eyes to become sensitive to sunlight. Wearing sunglasses may help.


• Urispas is not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Urispas, discuss with your doctor the benefits and risks of using Urispas during pregnancy. It is unknown if Urispas is excreted in breast milk. If you are or will be breast-feeding while you are using Urispas, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Urispas:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; decreased sweating; difficulty sleeping; dizziness; drowsiness; dry mouth; headache; loss of taste; nausea; nervousness.

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); diarrhea; difficulty focusing your eyes; difficulty urinating; rapid heart rate; unusual weakness; vomiting.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Urispas 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. Symptoms may include blurred vision; difficulty breathing; dilated pupils; disorientation; excessive thirst; flushed, hot, dry skin; muscle weakness; nausea; restlessness; seizures; unusual dizziness or drowsiness; unusually dry mouth; vomiting.

Proper storage of Urispas:

Store Urispas at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Urispas out of the reach of children and away from pets.

General information:

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


• Urispas 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 Urispas. 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 Urispas resources

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

• Urispas Prescribing Information (FDA)


• Urispas Advanced Consumer (Micromedex) - Includes Dosage Information


• Urispas Concise Consumer Information (Cerner Multum)


• Urispas Monograph (AHFS DI)


• Flavoxate Prescribing Information (FDA)


• Flavoxate Professional Patient Advice (Wolters Kluwer)

Compare Urispas with other medications

• Dysuria
• Overactive Bladder
• Urinary Incontinence

Tetravet

Dosage Form: FOR ANIMAL USE ONLY
Tetravet-CA™

(OXYTETRACYCLINE HCl) • AN ANTIBIOTIC

FOR USE IN DRINKING WATER ONLY • NOT FOR USE IN LIQUID FEED SUPPLEMENTS

This packet contains 648 grams of oxytetracycline HCl • This packet will treat 64,800 pounds of swine

MIXING DIRECTIONS FOR WATER MEDICATION

	Disease	Treatment Level
S W I N E	FOR THE CONTROL AND TREATMENT OF THE FOLLOWING DISEASES IN SWINE – Bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis, susceptible to oxytetracycline. Bacterial pneumonia caused by Pasteurella multocida, susceptible to oxytetracycline. FOR BREEDING SWINE: Leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona, susceptible to oxytetracycline.	10 mg/lb body weight

DIRECTIONS FOR USE

Mix fresh solutions daily. Use as sole source of drinking water. Do not mix this product directly with-milk or milk replacers. Administer one hour before or two hours after feeding milk or milk replacers. Administer for up to 5 days to swine.

NOTE: The concentration of drug required in medicated water must be adequate to compensate for variation in the age of the animal, feed consumption rate and the environmental temperatures and humidity, each of which affects water consumption.

RECOMMENDED PACKET STORAGE CONDITIONS

Store below 77° F (25° C)

PRECAUTION

Use as sole source of oxytetracycline. Not to be used for more than 5 consecutive days in swine.

LIVESTOCK REMEDY. NOT FOR HUMAN CONSUMPTION. HAZARDOUS REMEDY.

KEEP OUT OF REACH OF CHILDREN

Alpharma Inc.

Bridgewater, New Jersey 08807

Net wt. 3.91 lbs (1772 grams)

Tetravet-CA is a trademark of Alpharma Inc.

ALPHARMA & ALPHARMA logo are registered

trademarks of Alpharma Inc.

NADA # 130-435,

Approved by FDA

List #2203

2203BF 0907

PRINCIPAL DISPLAY PANEL - 1772 gram Packet

Tetravet-CA™

(OXYTETRACYCLINE HCl) • AN ANTIBIOTIC

FOR USE IN DRINKING WATER ONLY • NOT FOR USE IN LIQUID FEED SUPPLEMENTS

This packet contains 648 grams of oxytetracycline HCl • This packet will treat 64,800 pounds of swine

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

Tetravet-CA™

(OXYTETRACYCLINE HCl) • AN ANTIBIOTIC

FOR USE IN DRINKING WATER ONLY • NOT FOR USE IN LIQUID FEED SUPPLEMENTS

This packet contains 648 grams of oxytetracycline HCl • This packet will treat 64,800 pounds of swine

Tetravet  -CA oxytetracycline hydrochloride  powder, for solution

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 46573-223 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxytetracycline hydrochloride (Oxytetracycline) Oxytetracycline 648 g  in 1772 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 46573-223-46 6 PACKET In 1 CONTAINER contains a PACKET (46573-223-78) 1 46573-223-78 1772 g In 1 PACKET This package is contained within the CONTAINER (46573-223-46)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA130435	01/01/2009

Labeler - Alpharma Inc. Animal Health (070954094)

Revised: 07/2009Alpharma Inc. Animal Health

HyoMax FT

Generic Name: hyoscyamine (hye oh SYE a meen)

Brand Names: Anaspaz, Cystospaz, Ed Spaz, HyoMax, HyoMax DT, HyoMax FT, HyoMax SL, HyoMax SR, Hyospaz, Hyosyne, IB-Stat, Levbid, Levsin, Levsin SL, Levsinex SR, NuLev, Nulev, Symax Duotab, Symax FasTab, Symax SL, Symax SR

What is HyoMax FT (hyoscyamine)?

Hyoscyamine produces many effects in the body, including relief from muscle spasms.

Hyoscyamine also reduces the fluid secretions of many organs and glands in the body, such as the stomach, pancreas, lungs, saliva glands, sweat glands, and nasal passages.

Hyoscyamine is used to treat many different stomach and intestinal disorders, including peptic ulcer and irritable bowel syndrome. It is also used to control muscle spasms in the bladder, kidneys, or digestive tract, and to reduce stomach acid. Hyoscyamine is sometimes used to reduce tremors and rigid muscles in people with symptoms of Parkinson's disease.

Hyoscyamine is also used as a drying agent to control excessive salivation, runny nose, or excessive sweating.

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

What is the most important information I should know about HyoMax FT (hyoscyamine)?

Do not take hyoscyamine if you are allergic to it, or if you have kidney disease, a bladder or intestinal obstruction, severe ulcerative colitis, toxic megacolon, glaucoma, or myasthenia gravis.

Before taking hyoscyamine, tell your doctor if you have heart disease, congestive heart failure, a heart rhythm disorder, high blood pressure, overactive thyroid, or hiatal hernia with gastroesophageal reflux disease.

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

What should I discuss with my healthcare provider before taking HyoMax FT (hyoscyamine)?

Do not take hyoscyamine if you are allergic to it, or if you have:

• kidney disease;


• 
  

  an enlarged prostate or problems with urination;

  
  


• 
  

  intestinal blockage;

  
  


• 
  

  severe ulcerative colitis, or toxic megacolon;

  
  


• 
  

  glaucoma; or

  
  


• 
  

  myasthenia gravis.

  
  

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

• 
  

  heart disease, congestive heart failure;

  
  


• 
  

  a heart rhythm disorder;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  overactive thyroid; or

  
  


• 
  

  hiatal hernia with GERD (gastroesophageal reflux disease).

  
  

FDA pregnancy category C. It is not known whether hyoscyamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hyoscyamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take HyoMax FT (hyoscyamine)?

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.

Your medication may come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Hyoscyamine is usually taken before a meal. Follow your doctor's instructions.

Do not crush, chew, or open an extended-release tablet or capsule. It is specially made to release medicine slowly in the body. Breaking or crushing the pill would cause too much of the drug to be released at one time. Your doctor may want you to break an extended-release tablet and take only half of it. Follow your doctor's instructions.

Measure the oral liquid form of hyoscyamine 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.

The sublingual tablet form of this medication must be placed under the tongue, where it will dissolve. Do not swallow the sublingual tablet whole or wash it down with water. You may drink water after the pill has completely dissolved in your mouth.

Before using hyoscyamine oral spray for the first time, you must prime the spray pump. To do this, spray 3 test sprays into the air and away from your face. Prime the spray pump at least 1 test spray any time you have not used the oral spray for longer than 2 days. Spray until a fine mist appears.

After using the oral spray, try not to swallow right away. Do not rinse your mouth or spit for 5 to 10 minutes after using the oral spray.

Store this medication at room temperature away from moisture and heat.

Do not use hyoscyamine oral spray for more than 30 sprays, even if there is medicine still left in the bottle.

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 headache, dizziness, dry mouth, trouble swallowing, nausea, vomiting, blurred vision, hot dry skin, and feeling restless or nervous.

What should I avoid while taking HyoMax FT (hyoscyamine)?

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

HyoMax FT (hyoscyamine) 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 hyoscyamine and call your doctor at once if you have any of these serious side effects:

• 
  

  diarrhea;

  
  


• 
  

  confusion, hallucinations;

  
  


• 
  

  unusual thoughts or behavior;

  
  


• 
  

  fast, pounding, or uneven heart rate;

  
  


• 
  

  rash or flushing (warmth, redness, or tingly feeling); or

  
  


• 
  

  eye pain.

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness, feeling nervous;

  
  


• 
  

  blurred vision, headache;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  nausea, vomiting, bloating, heartburn, or constipation;

  
  


• 
  

  changes in taste;

  
  


• 
  

  problems with urination;

  
  


• 
  

  decreased sweating;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  impotence, loss of interest in sex, or trouble having an orgasm.

  
  

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 HyoMax FT (hyoscyamine)?

Tell your doctor about all other medicines you use, especially:

• 
  

  amantadine (Symmetrel);

  
  


• 
  

  haloperidol (Haldol);

  
  


• 
  

  an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

  
  


• 
  

  phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with hyoscyamine. 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 HyoMax FT resources

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

• Hyoscyamine Monograph (AHFS DI)


• Hyoscyamine MedFacts Consumer Leaflet (Wolters Kluwer)


• Anaspaz MedFacts Consumer Leaflet (Wolters Kluwer)


• HyoMax Prescribing Information (FDA)


• Hyosyne Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Hyosyne Prescribing Information (FDA)


• IB-Stat Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• Levbid Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Levsin Prescribing Information (FDA)


• NuLev Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Symax Duotab Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare HyoMax FT with other medications

• Anesthesia
• Crohn's Disease
• Endoscopy or Radiology Premedication
• Irritable Bowel Syndrome
• Urinary Incontinence

Where can I get more information?

• Your pharmacist can provide more information about hyoscyamine.

See also: HyoMax FT side effects (in more detail)