Trade Name: Donnatal

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: VistaPharm, Inc.

Presentation: ELIXIR, HUMAN PRESCRIPTION DRUG

Strength: 16.2; .1037; .0194; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL

Storage and handling

PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
  • No data
  • Donnataln- u00ae n- Elixir - Grape
  • Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:
  • PHENobarbital, USP.............................................16.2 mgn Hyoscyamine Sulfate, USP...............................0.1037 mgn Atropine Sulfate, USP.......................................0.0194 mgn Scopolamine Hydrobromide, USP....................0.0065 mg
  • Inactive Ingredients
  • Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1.
  • Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1.
  • This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.
  • No data
  • PHENobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement.
  • Donnatalu00ae Elixir can cause fetal harm when administered to a pregnant woman. Animal reproduction studies have not been conducted with Donnatalu00ae Elixir. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
  • In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating).
  • Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.
  • Donnatalu00ae Elixir may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work.
  • PHENobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.
  • PHENobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs.
  • Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.
  • No data
  • Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria, and other dermal manifestations; and decreased sweating.
  • Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema, and similar conditions. Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. Rarely, exfoliative dermatitis (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by PHENobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. In a few cases, megaloblastic anemia has been associated with the chronic use of PHENobarbital.
  • PHENobarbital may produce excitement in some patients, rather than a sedative effect.
  • To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm,u00a0Inc. at 1-888-655-1505 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride should be used.
  • The dosage of Donnatalu00ae Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
  • Donnatalu00ae Elixir. Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.
  • Pediatric patients: may be dosed every 4 to 6 hours. Use a pediatric dosing device or oral syringe to measure the dose.
  • Donnatalu00ae Elixir - Grape
  • Avoid Freezing
  • Store Donnatalu00ae Elixir at 20u00ba- 25u00baC (68u00ba - 77u00baF) [see USP Controlled Room Temperature]. Protect from light and moisture.
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • Distributed By:
  • VistaPharm, Inc.Largo, FL 33771
  • VP2189
  • Rev. 05/2017
  • Made in USA.
  • NDC 66689-063-01 5u00a0mL unit-dose cup
  • Donnataln (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)
  • Elixir grape flavored
  • Each 5 mL (1 teaspoonful) contains:
  • Phenobarbital, USP.............................. 16.2 mgHyoscyamine Sulfate, USP............... 0.1037 mgAtropine Sulfate, USP...................... 0.0194 mgScopolamine Hydrobromide, USP.... 0.0065 mg
  • Alcohol not more than 23.8%
  • Rx only
  • Store at 20u00b0-25u00b0C (68u00b0-77u00b0F) [see USP Controlled Room Temperature].
  • Avoid freezing.
  • Protect from light and moisture.

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide (Donnatal) which is also known as Donnatal and Manufactured by VistaPharm, Inc.. It is available in strength of 16.2; .1037; .0194; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL.

phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide (Donnatal) 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.

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