Maprotibene may be available in the countries listed below.
Maprotiline hydrochloride (a derivative of Maprotiline) is reported as an ingredient of Maprotibene in the following countries:
International Drug Name Search
Generic Name: pancrelipase (oral) (pan kre LYE pace)
Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep
Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.
Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.
Pancrelipase may also be used following surgical removal of the pancreas.
Pancrelipase may also be used for other purposes not listed in this medication guide.
Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.
Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.
If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.
If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:
gout;
a history of blockage in your intestines;
a sudden onset of pancreatitis; or
worsening of chronic pancreatic disease.
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.
Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.
You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.
Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
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.
Overdose symptoms may include diarrhea or stomach upset.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Less serious side effects may include:
nausea or vomiting;
mild stomach pain or upset;
diarrhea or constipation;
bloating or gas.
greasy stools;
rectal irritation;
headache, dizziness;
cough; or
weight loss.
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.
There may be other drugs that can interact with pancrelipase. 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.
See also: Cotazym side effects (in more detail)
Generic Name: Doxapram Hydrochloride
Class: Anorexigenic Agents and Respiratory and Cerebral Stimulants, Miscellaneous
VA Class: RE900
CAS Number: 7081-53-0
CNS stimulant; a monohydrated pyrrolidinone derivative.128 a
Treatment of drug-induced postanesthetic respiratory depression or apnea not caused by skeletal muscle relaxants.127 a
Other supportive therapy preferred due to questionable benefit and high potential for toxicity with doxapram.a Limited role due to availability of safer and shorter-acting anesthetic agents.128
Has been used in conjunction with supportive measures to stimulate respiration and hasten arousal in patients with respiratory and CNS depression secondary to drug overdose (e.g., barbiturates, opiate analgesics, general anesthetics).127 a
However, use as an analeptic is strongly discouraged by most clinicians;a analeptic therapy largely abandoned in favor of intensive supportive care (e.g., mechanical ventilation, oxygenation, cardiovascular support) and specific antidotes (e.g., pure opiate antagonists).135 a
Short-term use in patients with acute respiratory insufficiency associated with COPD.127 a
Role in such patients is limited; other supportive therapy (i.e., noninvasive ventilation using either negative- or positive-pressure device) is preferred.132 133 134 a
Has been used for the treatment of neonatal apnea†,100 101 102 103 104 105 106 107 108 120 121 123 124 125 principally in combination with theophylline104 105 106 120 or caffeine.107
Limited support for this use; no apparent advantage over methylxanthines and risk of substantial adverse effects with doxapram therapy.128 130 131 The commercially available injection contains benzyl alcohol; use of this preparation in neonates is not recommended.110 117 118 120 127 136 (See Pediatric Use under Cautions.)
Should not be used in conjunction with mechanical ventilation.127
Establish adequate airway and oxygenation prior to administration; take measures to prevent vomiting and aspiration.127 a
Use minimum effective dosage to avoid adverse effects.127 a
Monitor BP, heart rate, and deep tendon reflexes; adjust dosage or rate of infusion accordingly.127 Monitor for recurrence of unconsciousness or development of respiratory depression; provide supportive care as required.127
For solution and drug compatibility information, see Compatibility under Stability.
Administer by IV injection or IV infusion.127 a
Predictable blood gas patterns in patients with COPD and acute hypercapnia are more readily established with IV infusion therapy.127
Avoid extravasation and repeated use of a single injection site to minimize local reactions and thrombophlebitis.127 a
Prepare 1-mg/mL solution by adding 250 mg of doxapram hydrochloride (12.5 mL) to 250 mL of 5% dextrose, 10% dextrose, or 0.9% sodium chloride injection.127
Prepare 2-mg/mL solution by adding 400 mg of doxapram hydrochloride (20 mL) to 180 mL of 5% dextrose, 10% dextrose, or 0.9% sodium chloride injection.127
Rapid infusion may result in hemolysis; infuse diluted solution at slow rate.127 a
Postanesthetic use: Initiate IV infusion with 1-mg/mL solution at a rate of approximately 5 mg/minute until desired response achieved; usual maintenance rate is 1–3 mg/minute.127
Acute hypercapnia associated with COPD: Initiate IV infusion with 2-mg/mL solution at a rate of 1–2 mg/minute; may increase to maximum rate of 3 mg/minute.127
Available as doxapram hydrochloride; dosage expressed in terms of the salt.127
Children ≥12 years of age: 0.5–1 mg/kg as a single injection; may repeat every 5 minutes to a maximum total dosage of 2 mg/kg.127
Children ≥12 years of age: 0.5–1 mg/kg, up to a maximum dosage of 4 mg/kg.127
Children ≥12 years of age: Initiate at a rate of 1–2 mg/minute; increase to a maximum rate of 3 mg/minute if indicated.127 Continuation beyond a single 2-hour infusion not recommended.127 a
0.5–1 mg/kg as a single injection; may repeat every 5 minutes to a maximum total dosage of 2 mg/kg.127
0.5–1 mg/kg, up to a maximum dosage of 4 mg/kg.127
Initiate at a rate of 1–2 mg/minute; increase to a maximum rate of 3 mg/minute if indicated.127 Continuation beyond a single 2-hour infusion not recommended.127 a
Children ≥12 years of age: Maximum 1.5 mg/kg for a single injection, 2-mg/kg total dosage for repeat injections; do not exceed 3 g daily.127
Children ≥12 years of age: Maximum 4 mg/kg; do not exceed 3 g daily.127
Children ≥12 years of age: Maximum 3 mg/minute.127 Limit use to a single 2-hour infusion.127
Maximum 1.5 mg/kg for a single injection, 2-mg/kg total dosage for repeat injections; do not exceed 3 g daily.127
Maximum 4 mg/kg; do not exceed 3 g daily.127
Maximum 3 mg/minute.127 Limit use to a single 2-hour infusion.127
No special population dosage recommendations at this time.127
Known hypersensitivity to doxapram or any ingredient in the formulation.127 a
Seizure disorders.127 a
Suspected or confirmed pulmonary embolism.127 a
Mechanical disorders of ventilation (e.g., mechanical obstruction, muscle paresis, flail chest, pneumothorax, acute bronchial asthma, pulmonary fibrosis or other restrictive lung diseases).127 a
Head injury, cerebrovascular accident, or cerebral edema.127 a
Substantial cardiovascular impairment (i.e., uncompensated heart failure, severe CAD).127 a
Severe hypertension including that associated with hyperthyroidism or pheochromocytoma.127 a (See Postanesthetic Use under Cautions.)
Doxapram hydrochloride injection contains benzyl alcohol as a preservative, which has been associated with toxicity (including deaths) in neonates.109 110 111 112 113 114 115 116 117 122 127 Use of this preparation in neonates is not recommended.110 117 118 120 127 (See Pediatric Use under Cautions.)
Do not use doxapram in conjunction with mechanical ventilation.127 a
Doxapram is not an antagonist to muscle relaxants nor a specific opiate antagonist.127 Assess adequacy of ventilation with specific tests (e.g., peripheral nerve stimulation, airway pressures, head lift, pulse oximetry, end-tidal carbon dioxide) prior to use.127
Narcosis may recur; observe patient closely until fully alert for 0.5–1 hour.127
Concomitant use with a volatile general anesthetic may increase potential for arrhythmias.127 (See Specific Drugs under Interactions.)
Use with caution in patients with hypermetabolic states (e.g., hyperthyroidism, pheochromocytoma).127
May not be effective in patients with severe CNS or respiratory depression; manufacturers state that doxapram may be used adjunctively with established supportive and resuscitative measures.127
If no response, perform neurologic evaluation to identify other potential causes of sustained coma.127
Do not increase rate of infusion to lower carbon dioxide tension.127
Arrhythmias have been reported in patients with acute respiratory failure secondary to COPD.127 a Use with caution in these patients.127
To prevent respiratory acidosis in patients with COPD, monitor arterial blood gases at baseline and every 30 minutes. 127 Discontinue drug and initiate mechanical ventilation if arterial blood gases deteriorate.127
Use does not reduce need for supplemental oxygen.127
Possible changes in heart rate, lowered T-waves, and dysrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, QT interval prolongation).127 128 a Use with caution and monitor cardiac rhythm.127 a
Increases in BP usually are modest, but substantial increases reported.127 Avoid use in patients with severe hypertension.127 (See Contraindications under Cautions.)
Chest pain and tightness in chest also reported.127 a
Discontinue drug if sudden hypotension develops.127 a
Establish and protect airways.127
Discontinue drug if sudden dyspnea develops.127
Lowered carbon dioxide tension induced by hyperventilation may cause cerebral vasoconstriction and decreased cerebral circulation.127 a Pressor effect on pulmonary circulation may lead to decreased arterial oxygen tension.127 Monitor arterial blood gases.127
May cause seizures and other adverse effects due to general CNS stimulation.127 a Anticonvulsants, oxygen, and resuscitative equipment should be readily available; carefully observe patient and administer drug slowly if treatment continued.127
Potential for local reactions including thrombophlebitis; administer dilute solutions at a slow rate, prevent extravasation, and avoid repeated use of a single injection site.127 a
Rapid infusion may result in hemolysis.127 a (See Rate of Administration under Dosage and Administration.)
Category B.127 129
Not known whether doxapram is distributed into milk;127 however, molecular weight of free base suggests drug may be distributed into milk.129
Benzyl alcohol in commercial preparation is associated with toxicity in neonates; caution if used in nursing women.127 (See Pediatric Use under Cautions.)
Safety and efficacy not established in children <12 years of age.127 a
Each mL of doxapram hydrochloride injection contains 9 mg of benzyl alcohol;109 use of this preparation in neonates is not recommended.110 117 118 120 127 Although a causal relationship has not been established, large amounts of benzyl alcohol (100–400 mg/kg daily) have been associated with toxicity in neonates.109 110 111 112 113 114 115 116 117 122 127
Use with caution.127 Possible decrease in rate of metabolism or clearance in patients with substantial hepatic impairment.127
Use with caution.127 Possible decrease in rate of metabolism or clearance in patients with substantial renal impairment.127
Cough,127 128 dyspnea,127 128 tachypnea,127 128 headache,127 128 dizziness,127 128 apprehension,127 128 hypertension,127 128 flushing,127 128 sweating,127 128 nausea,127 128 vomiting,127 128 diarrhea,127 128 urinary retention,127 128 muscle spasticity.127 128
Drug | Interaction | Comments |
|---|---|---|
Anesthetics, inhalation (known to sensitize myocardium to catecholamines) | May increase potential for arrhythmias including ventricular tachycardia and ventricular fibrillation127 a Increased BUN and albuminuria observeda | Delay administration of doxapram until anesthetic excreted127 Importance of observed increase in BUN and albuminuria not establisheda |
CNS depressants | Increased BUN and albuminuria observeda | Importance not establisheda |
MAO inhibitors | Possible synergistic pressor effect127 a | Use with caution127 a |
Neuromuscular blocking agents | May temporarily mask residual effects of muscle relaxants127 | Use with cautiona |
Sympathomimetic agents | Possible synergistic pressor effect127 a | Use with caution127 a |
Theophyllines (e.g., aminophylline) | Possible increased skeletal muscle activity, agitation, and hyperactivity127 |
Following single IV injection, onset of respiratory stimulation occurs within 20–40 seconds and peaks at 1–2 minutes.127
Duration of respiratory stimulation may vary from 5–12 minutes following single IV injection.127
Doxapram and its metabolites are generally well distributed into tissues in animals.a
Rapidly metabolized following single IV dose.128 a Undergoes hydroxylation to ketodoxapram, an active metabolite.136
Excreted mainly in urine and feces as metabolites within 24–48 hours following administration;128 a following single IV dose, 40–50% of dose recovered in urine as metabolites;128 small amounts of metabolites may continue to be excreted for up to 120 hours.a
Elimination half-life approximately 6.6–9.9 hours in premature neonates receiving IV infusions of doxapram.124 125 126
20–25°C.127
For information on systemic interactions resulting from concomitant use, see Interactions.
Incompatible with strongly alkaline drugs or solutions.127 a
Compatible |
|---|
Dextrose 5 or 10% in water |
Sodium chloride 0.9% |
Incompatible |
|---|
Aminophylline |
Furosemide |
Sodium bicarbonate |
Thiopental sodium |
Ticarcillin |
Compatible |
|---|
Ampicillin sodium |
Caffeine citrate |
Calcium chloride |
Calcium gluconate |
Cefazolin sodium |
Ceftazidime |
Erythromycin lactobionate |
Fentanyl citrate |
Gentamicin sulfate |
Heparin sodium |
Metoclopramide HCl |
Metronidazole |
Oxacillin sodium |
Phenobarbital sodium |
Ranitidine HCl |
Vancomycin HCl |
Incompatible |
Clindamycin phosphate |
Compatible |
|---|
Amikacin sulfate |
Bumetanide |
Chlorpromazine HCl |
Cimetidine HCl |
Cisplatin |
Cyclophosphamide |
Dopamine HCl |
Doxycycline hyclate |
Epinephrine HCl |
Hydroxyzine HCl |
Isoniazid |
Lincomycin HCl |
Methotrexate sodium |
Phytonadione |
Pyridoxine HCl |
Terbutaline sulfate |
Thiamine HCl |
Tobramycin sulfate |
Vincristine sulfate |
Incompatible |
Aminophylline |
Ascorbic acid injection |
Cefotaxime |
Cefuroxime sodium |
Dexamethasone sodium phosphate |
Diazepam |
Digoxin |
Dobutamine HCl |
Folic acid |
Furosemide |
Hydrocortisone sodium phosphate |
Hydrocortisone sodium succinate |
Ketamine HCl |
Methylprednisolone sodium succinate |
Thiopental sodium |
Stimulates peripheral carotid and aortic chemoreceptors and central respiratory centers in a dose-related manner.127 128 a May cause tonic-clonic seizures with excessive CNS stimulation. a
Transiently increases tidal volume with slight increase in respiratory rate.127 a
May elicit a pressor response due to improved cardiac output and increased release of catecholamines.127 No direct effect on peripheral blood vessels.a
Does not antagonize the analgesic effects of opiates.127
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular disease, seizure disorders).127
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.127
Importance of informing patients of other important precautionary information.127 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection | 20 mg/mL* | Dopram (with benzyl alcohol 0.9%) | Baxter |
Doxapram Hydrochloride Injection (with benzyl alcohol 0.9%) | Bedford |
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 January 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.
100. Burnard ED, Moore RG, Nichol H. A trial of doxapram in the recurrent apnea of prematurity. In: Stern L, Oh W, Friis-Hansen B, eds. Intensive care in the newborn. Vol. II. New York: Masson; 1978:143-8.
101. Alpan G, Eyal F, Sagi E et al. Doxapram in the treatment of idiopathic apnea of prematurity unresponsive to aminophylline. J Pediatr. 1984; 104:634-7. [IDIS 183784] [PubMed 6707826]
102. Hayakawa F, Hakamada S, Kuno K et al. Doxapram in the treatment of idiopathic apnea of prematurity: desirable dosage and serum concentrations. J Pediatr. 1986; 109:138-40. [IDIS 218527] [PubMed 3723234]
103. Barrington K, Torok-Both G, Finer N et al. Dose-response relationship of doxapram in refractory idiopathic apnea of prematurity. Am Rev Respir Dis. 1986; 133(Suppl):A105. [IDIS 213882] [PubMed 3963628]
104. Eyal F, Alpan G, Sagi E et al. Aminophylline versus doxapram in idiopathic apnea of prematurity: a double-blind controlled study. Pediatrics. 1985; 75:709-13. [IDIS 198191] [PubMed 3982903]
105. Sagi E, Eyal F, Alpan G et al. Idiopathic apnoea of prematurity treated with doxapram and aminophylline. Arch Dis Child. 1984; 59:281-3. [IDIS 184062] [PubMed 6424586]
106. Barrington KJ, Finer NN, Peters KL et al. Physiologic effects of doxapram in idiopathic apnea of prematurity. J Pediatr. 1986; 108:125-9.
107. Bairam A, Vert P. Low-dose doxapram for apnoea of prematurity. Lancet. 1986; 1:793-4. [IDIS 213923] [PubMed 2870280]
108. Martin RJ, Miller MJ, Carlo WA. Pathogenesis of apnea in preterm infants. J Pediatr. 1986; 109:733-41. [PubMed 3095518]
109. AH Robins Company. Dopram (doxapram hydrochloride) injection prescribing information. In: Huff BB, ed. Physicians’ desk reference. 43rd ed. Medical Economics Company Inc: Oradell, NJ; 1989:1693-5.
110. Food and Drug Administration. Parenteral drug products containing benzyl alcohol or other preservatives; intent and request for information. Notice of intent. [21 CFR Ch 1, Subchapter C; Docket No. 85N-0043] Fed Regist. 1985; 50:20233-5.
111. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics. 1983; 72:356-8. [IDIS 175725] [PubMed 6889041]
112. Anon. Benzyl alcohol may be toxic to newborns. FDA Drug Bull. 1982; 12(2):10-1.
113. Anon. Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982; 31:290-1. [IDIS 150868] [PubMed 6810084]
114. Gershanik J, Boecler B, Ensley H et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982; 307:1384-8. [IDIS 160823] [PubMed 7133084]
115. Menon PA, Thach BT, Smith CH et al. Benzyl alcohol toxicity in a neonatal intensive care unit: incidence, symptomatology, and mortality. Am J Perinatol. 1984; 1:288-92. [PubMed 6440575]
116. Anderson CW, Ng KJ, Andresen B et al. Benzyl alcohol poisoning in a premature newborn infant. Am J Obstet Gynecol. 1984; 148:344-6. [IDIS 181207] [PubMed 6695984]
117. Jordan GD, Themelis NJ, Messerly SO et al. Doxapram and potential benzyl alcohol toxicity: a moratorium on clinical investigation? Pediatrics. 1986; 78:540-1. Letter. (IDIS 220422)
118. Jackson D. Doxapram and potential benzyl alcohol toxicity: a moratorium on clinical investigation? Pediatrics. 1986; 78:541. Reply. (IDIS 220423)
119. Cater G. Doxapram for apnea of prematurity. J Pediatr. 1987; 109:563.
120. Barrington KJ, Finer NN, Torok-Both G et al. Dose-response relationship of doxapram in the therapy for refractory idiopathic apnea of prematurity. Pediatrics. 1987; 80:22-7. [IDIS 231947] [PubMed 3110729]
121. Barrington KJ, Finer NN. Doxapram for apnea of prematurity. J Pediatr. 1987; 109:563.
122. Hiller JL, Benda GI, Rahatzad M et al. Benzyl alcohol toxicity: impact on mortality and intraventricular hemorrhage among very low birth weight infants. Pediatrics. 1986; 77:500-6. [IDIS 215931] [PubMed 3515306]
123. Peliowski A, Finer NN. A blinded, randomized, placebo-controlled trial to compare theophylline and doxapram for the treatment of apnea of prematurity. J Pediatr. 1990; 116:648-53. [IDIS 265255] [PubMed 2181103]
124. Barrington KJ, Finer NN, Torok-Both G et al. Dose-response relationship of doxapram in the therapy for refractory idiopathic apnea of prematurity. Pediatrics.
125. Jamali F, Barrington KJ, Finer NN et al. Doxapram dosage regimen in apnea of prematurity based on pharmacokinetic data. Dev Pharmacol Ther. 1988; 11:253-7. [PubMed 3191816]
126. Beaudry MA, Bradley JM, Gramlich LM et al. Pharmacokinetics of doxapram in idiopathic apnea of prematurity. Dev Pharmacol Ther. 1988; 11:65-72. [PubMed 3371147]
127. Bedford Laboratories. Doxapram hydrochloride injection prescribing information. Bedford, OH; 2005 Jan.
128. Yost CS. A new look at the respiratory stimulant doxapram. CNS Drug Rev. 2006; 12:236-49. [PubMed 17227289]
129. Doxapram. In: Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:511-12.
130. Henderson-Smart DJ, Steer P. Doxapram versus methylxanthines for apnea in preterm infants (review). Cochrane Database of Systematic Reviews. 2000, Issue 4. Article No: CD000075. DOI: 10.1002/14651858.CD000075.
131. Henderson-Smart DJ, Steer P. Doxapram treatment for apnea in preterm infants (review). Cochrane Database of Systematic Reviews. 2004, Issue 4. Article No: CD000074. DOI: 10.1002/14651858.CD000074.pub2.
132. National Heart, Lung, and Blood Institute/World Health Organization. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (brief summary). Bethesda, MD: National Heart, Lung, and Blood Institute, Global Initiative for Chronic Obstructive Lung Disease, World Health Organization; 2006. Available at: . Accessed 2007 Jun 29.
133. National Collaborating Centre for Chronic Conditions. Chronic obstructive pulmonary disease. National clinical guideline on management of chronic obstructive pulmonary disease in adults in primary and secondary care (brief summary). London, UK: National Institute for Clinical Excellence; 2004. Available at: . Accessed 2007 Jun 29.
134. Greenstone M, Lasserson TJ. Doxapram for ventilatory failure due to exacerbations of chronic obstructive pulmonary disease (review). Cochrane Database of Systematic Reviews. 2002, Issue 3. Article No: CD000223. DOI: 10.1002/14651858.CD000223.
135. Wax PM. Antiquated antidotes. In: Goldfrank LR, Flomenbaum NE, Lewin NA et al, eds. Goldfrank's toxicologic emergencies. 7th ed. New York: McGraw-Hill; 2002: 18-22.
136. Baxter Healthcare Corp. Dopram (doxapram) hydrochloride injection prescribing information. Deerfield, IL; 2006 May.
137. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:574-76.
a. AHFS drug information 2007. McEvoy GK, ed. Doxapram hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2484-5.
Rinpral may be available in the countries listed below.
Eperisone hydrochloride (a derivative of Eperisone) is reported as an ingredient of Rinpral in the following countries:
International Drug Name Search
In the US, Acamprosate (acamprosate systemic) is a member of the drug class drugs used in alcohol dependence and is used to treat Alcohol Dependence.
US matches:
Rec.INN
N07BB03
0077337-76-9
C5-H11-N-O4-S
181
Alcohol withdrawal agent
3-Acetamido-1-propanesulfonic acid
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Generic Name: dexamethasone nasal (dex a METH a sone)
Brand Names: Dexacort Phosphate in Turbinaire
Dexamethasone nasal was withdrawn from the U.S. market in 1998.
Dexamethasone is a steroid. It prevents the release of substances in the body that cause inflammation.
Dexamethasone nasal is also used to treat some types of nasal polyps.
Dexamethasone nasal may also be used for purposes other than those listed in this medication guide.
Dexamethasone nasal was withdrawn from the U.S. market in 1998.
Use dexamethasone nasal on a regular basis for best results. It may take several weeks to get the maximum effect of this medication.
Before taking this medication, tell your doctor if you have a viral, bacterial, or fungal infection of any kind. The absorption of this drug into your system can inhibit your body's ability to fight off infections. You may not be able to use dexamethasone nasal if you have an infection.
Use dexamethasone nasal spray exactly as directed by your doctor. Read the information insert included with your medication. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
If your nose is congested, try to clear it before using your medication to be sure that the medicine gets into your nasal passages. If you are also using a decongestant spray, use it to open up your nasal passages before using dexamethasone. However, do not use a decongestant spray unless your doctor approves.
Do not use more of this medication than is prescribed for you. Never use more than 12 sprays (1,008 micrograms) per day. It may take a few weeks to see the effects of dexamethasone nasal. Talk to your doctor if your symptoms do not improve or if they get worse.
Use the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.
An overdose of this medication is not likely to occur. If you do think that an overdose has occurred, call an emergency room or poison control center .
Avoid items or activities that you know are allergens for you if they make your symptoms worse. Clean areas where dust or pet fur may aggravate your condition.
Avoid exposing yourself to known sources of infection. Stay away from people with chicken pox, measles, or any other type of infection. Your immune system may not be strong enough to fight off an infection while you are using dexamethasone nasal.
Other, less serious side effects may be more likely to occur. Continue to use dexamethasone nasal and talk to your doctor if you experience
stinging or burning of the nose;
sneezing after application;
yeast infection in the nose or throat (white patches);
bleeding nose;
perforated septum (inside center of nose);
increased pressure in the eye, glaucoma, or tearing of the eyes;
headache or lightheadedness;
nausea;
nasal stuffiness or a runny nose; or
unpleasant (or loss of) taste or smell.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Before using this medication, tell your doctor and pharmacist about any other drugs you are taking. The use of other oral or inhaled steroids may increase the chance of side effects or overdose.
Drugs other than those listed here may also interact with dexamethasone nasal. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
Dexamethasone nasal was withdrawn from the U.S. market in 1998.
See also: Dexacort Phosphate in Turbinaire side effects (in more detail)
Flunarizine ratiopharm may be available in the countries listed below.
Flunarizine dihydrochloride (a derivative of Flunarizine) is reported as an ingredient of Flunarizine ratiopharm in the following countries:
International Drug Name Search
Class: Mucolytic Agents
ATC Class: R05CB13
VA Class: RE900
Chemical Name: Deoxyribonuclease
CAS Number: 9003-98-9
Brands: Pulmozyme
Mucolytic agent; biosynthetic (recombinant DNA origin) form of human deoxyribonuclease I (DNase I).1 2 33
Adjunctive therapy in patients with cystic fibrosis to reduce mucus viscosity and enable the clearance of airway secretions to improve pulmonary function (designated an orphan drug by FDA for this use).1 4 5 8 9 10 11 12 13 14 15 16 17 18 27 36
Reduces the frequency of respiratory infections requiring parenteral anti-infective therapy in patients with forced vital capacity (FVC) ≥40%.1 4 5 8 9 10 11 12 14 15 16 17 18 27 36
Administer by oral inhalation via nebulization once daily.1
Administer using a recommended nebulizer system; safety and efficacy of dornase alfa inhalation solution administered by a nebulizer system other than those listed below not established.1 1
Use in patients unable to inhale or exhale orally throughout the entire nebulization period.1
Nebulizer | Compressor |
|---|---|
Hudson T Up-draft II with | Pulmo-Aide |
Marquest Acorn II with | Pulmo-Aide |
PARI LC Jet+ with | PARI PRONEB |
PARI BABY with | PARI PRONEB |
Durable Sidestream with | Porta-Neb |
Durable Sidestream with | MOBILAIRE |
Oral inhalation solution should not be diluted nor mixed with any other drugs in the nebulizer.1
Empty the entire contents of the single-use ampul of solution into the nebulizer cup; attach the cup to the inhalation apparatus according to the manufacturer’s instructions.1 32
Place the mouthpiece of the nebulizer in the mouth and turn on the compressor.32 Breathe calmly and evenly through the mouth until the nebulizer stops producing a mist (duration of treatment for full dose is approximately 10–15 minutes).32
Clean the nebulizer after use according to the manufacturer's instructions.b
Oral inhalation solution contains no preservatives; once the single-use ampul is opened, use the entire contents or discard the remainder.1
Each single-use ampul delivers 2.5 mg (2.5 mL of undiluted solution) to the nebulizer cup.1 35
Children ≥5 years of age: 2.5 mg once daily.1 Some patients (e.g., those with FVC >85%) may benefit from 2.5 mg twice daily.1 35
2.5 mg once daily.1 Some patients (e.g., ≥21 years of age, those with FVC >85%) may benefit from 2.5 mg twice daily.1 35
In clinical studies, dosages >2.5 mg twice daily did not provide additional improvement in pulmonary function (e.g., FEV1).1 10
Safety and efficacy of daily administration for >12 months of continuous therapy not established.1
In clinical studies, dosages >2.5 mg twice daily did not provide additional improvement in pulmonary function (e.g., FEV1).1 10
Safety and efficacy of daily administration for >12 months of continuous therapy not established.1
No special population dosage recommendations at this time.a
Known hypersensitivity to dornase alfa, Chinese hamster ovary cell-derived products, or any ingredient in the formulation.a
Adjunct to and not a replacement for standard therapies (e.g., chest physical therapy, anti-infectives, bronchodilators, oral enzyme supplements, vitamins, oral and/or inhaled corticosteroids, analgesics); continue such therapies during enzyme therapy.1 31
Category B.a
Not known whether dornase alfa is distributed into milk; caution if used in nursing women.a
Limited experience in patients <5 years of age; use only in those in whom there is a potential for benefit in pulmonary function or in risk of respiratory tract infection.1
Increased incidence of cough, rhinitis, and rash in children <5 years of age compared with children ≥5 years of age.1
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.a
Pharyngitis, chest pain, voice alteration (e.g., hoarseness), rash, conjunctivitis.a
No formal drug interaction studies to date; however, the manufacturer states that concomitant administration of dornase alfa and other standard therapies for cystic fibrosis is safe and effective.a
Following oral inhalation, serum DNase concentrations were not increased above normal endogenous levels.a
Following oral inhalation, mean sputum DNase concentrations measurable within 15 minutes.a Improvement in pulmonary function (FEV1) evident within 8 days.a
Not known whether dornase alfa crosses the placenta or is distributed into milk.a
2–8°C; protect from light and excessive heat.a b Store ampuls in protective foil pouch to protect from light until used.a Discard if left at room temperature for ≥24 hours.b
Selectively cleaves extracellular DNA (e.g., in purulent pulmonary secretions);1 2 5 33 does not appear to affect sputum in the absence of an inflammatory response to infection (i.e., in those with nonpurulent sputum)2 5 8 35 nor does it affect pulmonary function in healthy individuals.8
Reduces sputum viscosity and viscoelasticity.1 2 3 15 20
Mechanism of action not fully elucidated;6 7 appears to improve the transportability of purulent mucus via ciliary activity and cough.3 19
Reduces airflow obstruction, improves pulmonary function (increased forced vital capacity and forced expiratory volume at 1 second [FEV1]), and improves mucociliary clearance in patients with cystic fibrosis.1 5 8 9 10 11 12 14 27 29
Importance of providing patient a copy of manufacturer's patient information.b
Importance of adequate understanding of proper storage, preparation, and inhalation techniques, including use of the nebulization delivery system.b
Importance of thoroughly washing hands with soap and water before handling drug and nebulizer to avoid microbial contamination.b
Importance of adhering to daily dosing schedule and concomitant therapies, including not exceeding the recommended dose or frequency of use unless otherwise instructed by a clinician.b
Importance of not diluting or mixing with other drugs in the nebulizer.1
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information.a (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral Inhalation | Solution, for nebulization | 1 mg/mL (2.5 mg) | Pulmozyme | Genentech |
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.
Pulmozyme 1MG/ML Solution (GENENTECH): 75/$2151.77 or 150/$4200.17
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 April 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Genentech, Inc. Pulmozyme (dornase alfa) inhalation solution prescribing information. South San Francisco, CA; 2001 Jan.
2. Shak S, Capon DJ, Hellmiss R et al. Recombinant human DNase I reduces the viscosity of cystic fibrosis sputum. Proc Natl Acad Sci USA. 1990; 87:9188-92. [PubMed 2251263]
3. Zahm JM, de Bentzmann S, Deneuville E et al. Recombinant human DNase I improves the transport of cystic fibrosis respiratory mucus ex vivo. Pediatr Pulmonol. 1993; Suppl 9:250.
4. Collins FS. Cystic fibrosis: molecular biology and therapeutic implications. Science. 1992; 256:774-9. [PubMed 1375392]
5. Hubbard RC, McElvaney NG, Birrer P et al. A preliminary study of aerosolized recombinant human deoxyribonuclease I in the treatment of cystic fibrosis. N Engl J Med. 1992; 326:812-5. [IDIS 293048] [PubMed 1538726]
6. Rubin BK. Aerosolized recombinant human deoxyribonuclease I in the treatment of cystic fibrosis. N Engl J Med. 1992; 327:571. [IDIS 300805] [PubMed 1635583]
7. Hubbard RC, Shak S, Crystal RG. Aerosolized recombinant human deoxyribonuclease I in the treatment of cystic fibrosis. N Engl J Med. 1992; 327:571.
8. Aitken ML, Burke W, McDonald G et al. Recombinant human DNase inhalation in normal subjects and patients with cystic fibrosis: a phase 1 study. JAMA. 1992; 267:1947-51. [IDIS 294316] [PubMed 1548827]
9. Fuchs HJ, Borowitz D, Christiansen D et al. Aerosolized recombinant human DNase reduces pulmonary exacerbations and improves pulmonary function in patients with cystic fibrosis. Presented at the 36th Annual Conference on Chest Disease, Intermountain Thoracic Society. Snowbird, UT: 1993 Jan 26.
10. Ramsey BW, Astley SJ, Aitken ML et al. Efficacy and safety of short-term administration of aerosolized recombinant human deoxyribonuclease in patients with cystic fibrosis. Am Rev Respir Dis. 1993; 148:145-51. [IDIS 316737] [PubMed 8317790]
11. Ranasinha C, Assoufi B, Shak S et al. Efficacy and safety of short-term administration of aerosolised recombinant human DNase I in adults with stable stage cystic fibrosis. Lancet. 1993; 342:199-202. [IDIS 318293] [PubMed 8100928]
12. Ramsey B for the Pulmozyme (rhDNase) Study Group. A summary of the results of the phase III multicenter clinical trial: aerosol administration of recombinant human DNase reduces the risk of respiratory tract infections and improves pulmonary function in patients with cystic fibrosis. Pediatr Pulmonol. 1993; Suppl 9:152-3.
13. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to August 31, 1993. Rockville, MD; 1993 September.
14. Quan MP. Manufacturer letter regarding product information on Pulmozyme (dornase alfa). South San Francisco, CA: Genentech, Inc; 1993 Aug 6.
15. Boucher RC. Drug therapy in the 1990s: what can we expect for cystic fibrosis? Drugs. 1992; 43:431-9.
16. Wallace CS, Hall M, Kuhn RJ. Pharmacologic management of cystic fibrosis. Clin Pharm. 1993; 12:657-74. [IDIS 319124] [PubMed 8306566]
17. Fiel SB. Clinical management of pulmonary disease in cystic fibrosis. Lancet. 1993; 341:1070-4. [IDIS 313065] [PubMed 8096969]
18. Gibaldi M. Understanding and treating some genetic diseases. Ann Pharmacother. 1992; 26:1589-94. [IDIS 306629] [PubMed 1482818]
19. Rubin BK, Ramirez OE, Baharav AL. The physical and transport properties of CF sputum after treatment with rhDNase. Pediatr Pulmonol. 1993; Suppl 9:251.
20. Shak S, King M. Effects of rhDNase on cystic fibrosis sputum viscoelasticity in vitro. Pediatr Pulmonol. 1993; Suppl 9:251.
21. Mucolytics. In: Goodman LS, Gilman A, Gilman AG et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 5th ed. New York: Macmillan Publishing Company; 1975:955-6.
22. Lieberman J. Dornase aerosol effect on sputum viscosity in cases of cystic fibrosis. JAMA. 1968; 205:114-5. [PubMed 5694890]
23. Lieberman J. The appropriate use of mucolytic agents. Am J Med. 1970; 49:1-4. [PubMed 4246985]
24. Puckett WH Jr. The pharmacist and inhalation therapy. Am J Hosp Pharm. 1972; 29:556-63. [PubMed 5052020]
25. Raskin P. Bronchospasm after inhalation of pancreatic dornase. Am Rev Respir Dis. 1968; 98:697-8. [PubMed 4877872]
26. Morice AH. Which DNase in cystic fibrosis? Lancet. 1993; 342:624-5. Letter.
27. Shah PL, Scott S, Geddes D et al. A preliminary report on using aerosolised recombinant human DNase I in the treatment of patients with stable stage cystic fibrosis for six months. Pediatr Pulmonol. 1993; Suppl 9:247.
28. Wilmott R, DNase Multicenter Study Group, Genentech Staff. A phase II, double-blind, multicenter study of the safety and efficacy of aerosolized recombinant human DNase I (rhDNase) in hospitalized patients with CF experiencing acute pulmonary exacerbations. Pediatr Pulmonol. 1993; Suppl 9:154.
29. Laube BL, Auci RM, Shields DE et al. A randomized, placebo-controlled trial of the effect of recombinant human DNase I (rhDNase) on the deposition homogeneity and mucociliary clearance of radioaerosol in patients with cystic fibrosis. Pediatr Pulmonol. 1993; Suppl 9:155-6.
30. Shah PL, Scott SF, Hodson ME. Report on a multicentre study using aerosolised recombinant human DNase I in the treatment of cystic fibrosis patients with severe pulmonary disease. Pediatr Pulmonol. 1993; Suppl 9:157.
31. Magnuson DE. Dear hospital pharmacist letter regarding the use of Pulmozyme in the management of patients with cystic fibrosis. South San Francisco, CA: Genentech, Inc; 1994 Jan 5.
32. Genentech, Inc. Patient information booklet: your guide to Pulmozyme (dornase alfa) therapy for cystic fibrosis (CF). South San Francisco, CA; 1994.
33. Webb EC, preparer. Enzyme nomenclature 1992: recommendations of the Nomenclature Committee of the International Union of Biochemistry and Molecular Biology on the nomenclature and classification of enzymes. San Diego, CA: Academic Press, Inc; 1992:339. ECC 3.1.21.1.
34. Armstrong JB, White JC. Liquefaction of viscous purulent exudates by deoxyribonuclease. Lancet. 1950; 1:739-42.
35. Genentech, South San Francisco, CA: Personal communication.
36. Genentech, Inc. Pulmozyme (dornase alfa) recombinant inhalation solution prescribing information. South San Francisco, CA; 1996 Nov.
37. McCoy K, Hamilton S, Johnson C. Effects of 12-week administration of dornase alfa in patients with advanced cystic fibrosis lung disease. Chest. 1996; 110:889-95. [IDIS 373898] [PubMed 8874241]
38. Kanga JF. Dornase alfa therapy in cystic fibrosis: who should get it? Chest. 1996; 110:871-2. Editorial.
a. Genentech, Inc. Pulmozyme (dornase alfa) inhalation solution prescribing information. South San Francisco, CA; 2005 Apr.
b. Genentech, Inc. Pulmozyme (dornase alfa) inhalation solution information for the patient/parent. South San Francisco, CA; 2001 Jan.
Coopercare may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Povidone-Iodine is reported as an ingredient of Coopercare in the following countries:
International Drug Name Search
Generic Name: nitroglycerin (Transdermal route)
nye-troe-GLIS-er-in
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Antianginal
Chemical Class: Nitrate
Nitroglycerin transdermal is used to prevent angina (chest pain) caused by coronary artery disease. It does not work fast enough to relieve the pain of an angina attack that has already started.
Nitroglycerin transdermal belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load. When used regularly on a long-term basis, this helps prevent angina attacks from occurring.
This medicine is available only with your doctor's prescription.
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of nitroglycerin transdermal in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nitroglycerin transdermal in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving nitroglycerin transdermal.
| 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. |
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.
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
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.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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:
This section provides information on the proper use of a number of products that contain nitroglycerin. It may not be specific to Nitro-Dur 0.8. Please read with care.
Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. It will only work if applied correctly.
This form of nitrate is used to reduce the number of angina attacks over a long time. It will not relieve an attack that has already started because it works too slowly. The ointment and patch forms release medicine gradually to provide an effect for 7 to 10 hours. Check with your doctor if you also need a fast-acting medicine to relieve the pain of an angina attack.
You should use this medicine first thing in the morning and follow the same schedule each day. This medicine works best if you have a "drug-free" period of time every day when you do not use it. Your doctor will schedule your doses during the day to allow for a drug-free time. Follow the schedule of dosing carefully so the medicine will work properly.
This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.
For patients using the ointment:
For patients using the patch system:
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.
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
After removing a used patch, fold it in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.
If you will be taking this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not take sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using this medicine. Using these medicines together may cause blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you experience an angina attack, you must go to the hospital right away.
This medicine may cause headaches. These headaches are a sign that the medicine is working. Do not stop using the medicine or change the time you use it in order to avoid the headaches. If you have severe pain, talk with your doctor.
Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.
Dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking this medicine, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.
Do not stop using this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.
Tell the doctor in charge that you are using this medicine before having a magnetic resonance imaging (MRI) scan. Skin burns may occur at the site where the patch is worn during this procedure. Ask your doctor if the patch should be removed before having an MRI scan. You might need to put on a new patch after the procedure.
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.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
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:
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: Nitro-Dur 0.8 side effects (in more detail)
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