What happens if I overdose Proral?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; severe dizziness or light-headedness; shortness of breath; swelling of the hands, ankles, or feet; trouble breathing; very slow heart rate.
Proper storage of Proral sustained-release capsules:
Store Proral sustained-release capsules 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 Proral sustained-release capsules out of the reach of children and away from pets.
Overdose of Proral in details
Most overdoses of Proral are mild and respond to supportive care.
Proral is not significantly dialyzable.
Hypotension and bradycardia have been reported following Proral overdose and should be treated appropriately. Glucagon can exert potent inotropic and chronotropic effects and may be particularly useful for the treatment of hypotension or depressed myocardial function after a Proral overdose.
Glucagon should be administered as 50-150 mcg/kg intravenously followed by continuous drip of 1-5 mg/hour for positive chronotropic effect. Isoproterenol, dopamine or phosphodiesterase inhibitors may also be useful. Epinephrine, however, may provoke uncontrolled hypertension. Bradycardia can be treated with atropine or isoproterenol. Serious bradycardia may require temporary cardiac pacing.
Monitor the electrocardiogram, pulse, blood pressure, neurobehavioral status and intake and output balance. Isoproterenol and aminophylline may be used for bronchospasm.
What should I avoid while taking Proral?
Avoid drinking alcohol. It may increase your blood levels of Proral.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Proral warnings
Hypoglycemia
Proral prevents the response of endogenous catecholamines to correct hypoglycemia and masks the adrenergic warning signs of hypoglycemia, particularly tachycardia, palpitations and sweating. Proral can cause hypoglycemia in children, especially when they are not feeding regularly or are vomiting; withhold the dose under these conditions. Hypoglycemia may present in the form of seizures, lethargy, or coma. If a child has clinical signs of hypoglycemia, discontinue Proral and call their health care provider immediately or take the child to the emergency room.
Concomitant treatment with corticosteroids may increase the risk of hypoglycemia.
Bradycardia and Hypotension
Proral may cause or worsen bradycardia or hypotension. In the studies of Proral for infantile hemangioma the mean decrease in heart rate was about 7 bpm with little effect on blood pressure. Monitor heart rate and blood pressure after treatment initiation or increase in dose. Discontinue treatment if severe (<80 beats per minute) or symptomatic bradycardia or hypotension (systolic blood pressure <50 mmHg) occurs.
Bronchospasm
Proral can cause bronchospasm; do not use in patients with asthma or a history of bronchospasm. Interrupt treatment in the event of a lower respiratory tract infection associated with dyspnea and wheezing.
Cardiac Failure
Sympathetic stimulation supports circulatory function in patients with congestive heart failure, beta blockade may precipitate more severe failure.
Increased Risk of Stroke in PHACE Syndrome
By dropping blood pressure, Proral may increase the risk of stroke in PHACE syndrome patients with severe cerebrovascular anomalies.
Investigate infants with large facial infantile hemangioma for potential arteriopathy associated with PHACE syndrome prior to Proral therapy.
Hypersensitivity
Beta-blockers will interfere with epinephrine used to treat serious anaphylaxis.
What should I discuss with my healthcare provider before taking Proral?
Some medical conditions may interact with Proral solution. Tell the doctor or pharmacist if your child has any medical conditions, especially if any of the following apply to your
Child:
- if your child is taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if your child has allergies to medicines, foods, or other substances
- if your child has a history of heart problems (eg, heart failure, slow heartbeat) or low blood pressure
Some MEDICINES MAY INTERACT with Proral solution. Tell the health care provider if your child is taking any other medicines, especially any of the following:
- Corticosteroids (eg, prednisone) because the risk of low blood sugar may be increased
- Phenobarbital, phenytoin, or rifampin because they may decrease Proral solution's effectiveness
- Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, heart problems, irregular heartbeat, diabetes, prostate problems, blood thinning, thyroid problems, depression, mental or mood problems, immune system suppression, allergic reactions, asthma or other lung or breathing problems, high cholesterol, seizures, multiple sclerosis [MS]), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) because they may interact with Proral solution. Ask the doctor or pharmacist if you are unsure if any of your child's medicines might interact with Proral solution
This may not be a complete list of all interactions that may occur. Ask the health care provider if Proral solution may interact with other medicines that your child takes. Check with the health care provider before your child starts, stops, or changes the dose of any medicine.
Proral precautions
General
Proral should be used with caution in patients with impaired hepatic or renal function. Proral is not indicated for the treatment of hypertensive emergencies.
Beta-adrenergic receptor blockade can cause reduction of intraocular pressure. Patients should be told that Proral may interfere with the glaucoma screening test. Withdrawal may lead to a return of increased intraocular pressure.
While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
Clinical Laboratory Tests
In patients with hypertension, use of Proral has been associated with elevated levels of serum potassium, serum transaminases, and alkaline phosphatase. In severe heart failure, the use of Proral has been associated with increases in Blood Urea Nitrogen.
Drug Interactions
Caution should be exercised when Proral is administered with drugs that have an affect on CYP2D6, 1A2, or 2C19 metabolic pathways. Co-administration of such drugs with Proral may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity.
Alcohol when used concomitantly with Proral, may increase plasma levels of Proral.
Cardiovascular Drugs
Antiarrhythmics
Propafenone has negative inotropic and beta-blocking properties that can be additive to those of Proral.
Quinidine increases the concentration of Proral and produces greater degrees of clinical beta-blockade and may cause postural hypotension.
Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as Proral.
The clearance of lidocaine is reduced with administration of Proral. Lidocaine toxicity has been reported following co-administration with Proral.
Caution should be exercised when administering Proral with drugs that slow A-V nodal conduction, e.g., lidocaine and calcium channel blockers.
Digitalis Glycosides
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Calcium Channel Blockers
Caution should be exercised when patients receiving a beta-blocker are administered a calcium-channel-blocking drug with negative inotropic and/or chronotropic effects. Both agents may depress myocardial contractility or atrioventricular conduction.
There have been reports of significant bradycardia, heart failure, and cardiovascular collapse with concurrent use of verapamil and beta-blockers.
Co-administration of Proral and diltiazem in patients with cardiac disease has been associated with bradycardia, hypotension, high degree heart block, and heart failure.
ACE Inhibitors
When combined with beta-blockers, ACE inhibitors can cause hypotension, particularly in the setting of acute myocardial infarction.
The antihypertensive effects of clonidine may be antagonized by beta-blockers. Proral should be administered cautiously to patients withdrawing from clonidine.
Alpha Blockers
Prazosin has been associated with prolongation of first dose hypotension in the presence of beta-blockers.
Postural hypotension has been reported in patients taking both beta-blockers and terazosin or doxazosin.
Reserpine
Patients receiving catecholamine-depleting drugs, such as reserpine should be closely observed for excessive reduction of resting sympathetic nervous activity, which may result in hypotension, marked bradycardia, vertigo, syncopal attacks, or orthostatic hypotension.
Inotropic Agents
Patients on long-term therapy with Proral may experience uncontrolled hypertension if administered epinephrine as a consequence of unopposed alpha-receptor stimulation. Epinephrine is therefore not indicated in the treatment of Proral overdose.
Isoproterenol and Dobutamine
Proral is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents, e.g., dobutamine or isoproterenol. Also, Proral may reduce sensitivity to dobutamine stress echocardiography in patients undergoing evaluation for myocardial ischemia.
Non-Cardiovascular Drugs
Nonsteroidal Anti-Inflammatory Drugs
Nonsteroidal anti-inflammatory drugs (NSAIDs) have been reported to blunt the antihypertensive effect of beta-adrenoreceptor blocking agents.
Administration of indomethacin with Proral may reduce the efficacy of Proral in reducing blood pressure and heart rate.
Antidepressants
The hypotensive effects of MAO inhibitors or tricyclic antidepressants may be exacerbated when administered with beta-blockers by interfering with the beta-blocking activity of Proral.
Anesthetic Agents
Methoxyflurane and trichloroethylene may depress myocardial contractility when administered with Proral.
Warfarin
Proral when administered with warfarin increases the concentration of warfarin. Prothrombin time, therefore, should be monitored.
Neuroleptic Drugs
Hypotension and cardiac arrest have been reported with the concomitant use of Proral and haloperidol.
Thyroxine
Thyroxine may result in a lower than expected T3 concentration when used concomitantly with Proral.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In dietary administration studies in which mice and rats were treated with Proral hydrochloride for up to 18 months at doses of up to 150 mg/kg/day, there was no evidence of drug-related tumorigenesis. On a body surface area basis, this dose in the mouse and rat is, respectively, about equal to and about twice the maximum recommended human oral daily dose (MRHD) of 640 mg Proral hydrochloride. In a study in which both male and female rats were exposed to Proral hydrochloride in their diets at concentrations of up to 0.05% (about 50 mg/kg body weight and less than the MRHD), from 60 days prior to mating and throughout pregnancy and lactation for two generations, there were no effects on fertility. Based on differing results from Ames Tests performed by different laboratories, there is equivocal evidence for a genotoxic effect of Proral in bacteria (S. typhimurium strain TA 1538).
Pregnancy: Pregnancy Category C
In a series of reproductive and developmental toxicology studies, Proral was given to rats by gavage or in the diet throughout pregnancy and lactation. At doses of 150 mg/kg/day, but not at doses of 80 mg/kg/day (equivalent to the MRHD on a body surface area basis), treatment was associated with embryotoxicity (reduced litter size and increased resorption rates) as well as neonatal toxicity (deaths). Proral hydrochloride also was administered (in the feed) to rabbits (throughout pregnancy and lactation) at doses as high as 150 mg/kg/day (about 5 times the maximum recommended human oral daily dose). No evidence of embryo or neonatal toxicity was noted.
There are no adequate and well-controlled studies in pregnant women. Intrauterine growth retardation, small placentas, and congenital abnormalities have been reported in neonates whose mothers received Proral during pregnancy. Neonates whose mothers are receiving Proral at parturition have exhibited bradycardia, hypoglycemia and/or respiratory depression. Adequate facilities for monitoring such infants at birth should be available. Proral should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
Proral is excreted in human milk. Caution should be exercised when Proral is administered to a nursing woman.
Pediatric Use
Safety and effectiveness of Proral in pediatric patients have not been established.
Bronchospasm and congestive heart failure have been reported coincident with the administration of Proral therapy in pediatric patients.
Geriatric Use
Clinical studies of Proral did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of the decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
What happens if I miss a dose of Proral?
For regular (short-acting) Proral: Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 4 hours away.
For extended-release Proral (Proral, InnoPran XL and others): Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 8 hours away.
Do not take extra medicine to make up the missed dose.
References
- DrugBank. "propranolol". http://www.drugbank.ca/drugs/DB00571 (accessed September 17, 2018).
- MeSH. "Vasodilator Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
Reviews
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
