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DIMENHYDRINATE Solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

Fresenius Kabi USA, LLC

Λέξεις κλειδιά

63323-366

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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1. Description

Dimenhydrinate, an anti-nauseant/antiemetic, is the 8-chlorotheophylline salt of diphenhydramine. It contains not less than 53% and not more than 55.5% of diphenhydramine, and not less than 44% and not ...

2. Clinical Pharmacology

While the precise mode of action of dimenhydrinate is not known, it has a depressant action on hyperstimulated labyrinthine function.

3. Indications and Usage

Dimenhydrinate Injection, USP is indicated for the prevention and treatment of nausea, vomiting, or vertigo of motion sickness.

4. Contraindications

Neonates and patients with a history of hypersensitivity to dimenhydrinate or its components (diphenhydramine or 8-chlorotheophylline) should not be treated with dimenhydrinate. <u>Note:</u> This product ...

5. Warnings

Caution should be used when dimenhydrinate is given in conjunction with certain antibiotics that may cause ototoxicity, since dimenhydrinate is capable of masking ototoxic symptoms, and an irreversible ...

6.1. General

Drowsiness may be experienced by some patients, especially with high dosage. This effect frequently is not undesirable in conditions for which the drug is used.

6.2. Information for Patients

Because of the potential for drowsiness, patients taking dimenhydrinate should be cautioned against operating automobiles or dangerous machinery (see WARNINGS).

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenicity screening tests performed with dimenhydrinate, diphenhydramine, and 8-chlorotheophylline produced positive results in the bacterial systems and negative results in the mammalian systems. There ...

6.7. Pregnancy

Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 20 times the human dose, and in rabbits at doses up to 25 times the human dose (on a mg/kg basis), and have revealed ...

6.8. Labor and Delivery

The safety of dimenhydrinate given during labor and delivery has not been established. Reports have indicated dimenhydrinate may have an oxytocic effect. Caution is advised when this effect is unwanted ...

6.9. Nursing Mothers

Small amounts of dimenhydrinate are excreted in breast milk. Because of the potential for adverse reactions in nursing infants from dimenhydrinate, a decision should be made whether to discontinue nursing ...

7. Adverse Reactions

The most frequent adverse reaction to dimenhydrinate is drowsiness. Dizziness may also occur. Symptoms of dry mouth, nose and throat, blurred vision, difficult or painful urination, headache, anorexia, ...

9. Overdosage

Drowsiness is the usual clinical side effect. Convulsions, coma, and respiratory depression may occur with massive overdosage. No specific antidote is known. If respiratory depression occurs, mechanically ...

10. Dosage and Administration

Dimenhydrinate in the injectable form is indicated when the oral form is impractical. Adults Nausea or vomiting may be expected to be controlled for approximately 4 hours with 50 mg, and prevented by a ...

11. How Supplied

DimenhyDRINATE Injection, USP, 50 mg/mL is available in multiple dose amber vials, as follows: Product No. NDC No. Strength Vial Size 361601 63323-366-01 50 mg/mL 1 mL in 2 mL vial, in packages of ...

12. Storage and Handling

Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Vial stoppers do not contain natural rubber latex.
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