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Propranolol Hydrochloride (Propranolol Hydrochloride)

Trade Name : Propranolol Hydrochloride

Amneal Pharmaceuticals of New York LLC

TABLET

Strength 60 mg/1

PROPRANOLOL HYDROCHLORIDE Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Propranolol Hydrochloride (Propranolol Hydrochloride) which is also known as Propranolol Hydrochloride and Manufactured by Amneal Pharmaceuticals of New York LLC. It is available in strength of 60 mg/1 per ml. Read more

Propranolol Hydrochloride (Propranolol Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(u00b1)-. Its structural formula is:
  • CHNOu2022HCln- M.W. 295.80
  • Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and in ethanol.
  • Propranolol hydrochloride tablets, USP are available as tablets for oral administration containing 60 mg of propranolol hydrochloride, USP. Propranolol hydrochloride tablets, USP also contain lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Color additives include FD&C Red no. 40 aluminum lake (60 mg).
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  • Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.
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  • In dietary administration studies in which mice and rats were treated with propranolol 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 propranolol hydrochloride. In a study in which both male and female rats were exposed to propranolol 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 propranolol hydrochloride in bacteria (S. strain TA 1538).
  • The following adverse events were observed and have been reported in patients using propranolol.
  • Cardiovascular
  • Bradycardia; congestive heart failure; intensification of AV block; hypotension; paresthesia of hands; thrombocytopenic purpura; arterial insufficiency, usually of the Raynaud type.
  • Central Nervous System
  • Light-headedness, mental depression manifested by insomnia, lassitude, weakness, fatigue; catatonia; visual disturbances; hallucinations; vivid dreams; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics. For immediate-release formulations, fatigue, lethargy, and vivid dreams appear dose-related.
  • Gastrointestinal
  • Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis.
  • Allergic
  • Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat; laryngospasm, and respiratory distress.
  • Respiratory
  • Bronchospasm.
  • Hematologic
  • Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.
  • Autoimmune
  • Systemic lupus erythematosus (SLE).
  • Skin and mucous membranes
  • Stevens-Johnson syndrome, toxic epidermal necrolysis, dry eyes, exfoliative dermatitis, erythema multiforme, urticaria, alopecia, SLE-like reactions, and psoriasiform rashes. Oculomucocutaneous syndrome involving the skin, serous membranes and conjunctivae reported for a beta blocker (practolol) have not been associated with propranolol.
  • Genitourinary
  • Male impotence; Peyronie's disease.n n
  • Propranolol is not significantly dialyzable. In the event of overdosage or exaggerated response, the following measures should be employed:
  • General: If ingestion is or may have been recent, evacuate gastric contents, taking care to prevent pulmonary aspiration.
  • Supportive Therapy: Hypotension and bradycardia have been reported following propranolol 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 propranolol overdose. Glucagon should be administered as 50 to 150 mcg/kg intravenously followed by continuous drip of 1 to 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.
  • The electrocardiogram, pulse, blood pressure, neurobehavioral status and intake and output balance must be monitored. Isoproterenol and aminophylline may be used for bronchospasm.
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  • Propranolol Hydrochloride Tablets, USP
  • 60 mg u2013 Pink, round, convex, debossed tablets on one side with PLIVA 470 and scored on the other side. Available in bottles of 100 (NDC: 011501).
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • PROTECT FROM LIGHT.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Manufactured In Czech Republic By:n Opava-Komarov, Czech Republicn Distributed By:n Bridgewater, NJ 08807n Rev. 02-2019-00
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