Drotaverine Hydrochloride Injection
- Packing: 2 Ml Ampoule.
- Available Strength : 20 Mg/Ml
Description
Product Description: Drotaverine Hydrochloride Injection is a pharmaceutical formulation designed to address smooth muscle spasms and related conditions. It contains drotaverine hydrochloride, a spasmolytic agent that acts directly on smooth muscles, relieving spasms and improving blood flow. This injection is formulated for rapid onset of action and efficient relief from conditions such as abdominal pain, biliary colic, dysmenorrhea, and other smooth muscle-related disorders.
Indications and Usage: Drotaverine Hydrochloride Injection is indicated for the symptomatic relief of smooth muscle spasms associated with various conditions, including gastrointestinal disorders such as irritable bowel syndrome and biliary colic, as well as gynecological conditions like dysmenorrhea. It is also used to facilitate smooth muscle relaxation during diagnostic and therapeutic procedures.
Dosage and Administration: The dosage of Drotaverine Hydrochloride Injection varies depending on the patient's age, weight, and the severity of symptoms. It is administered via intravenous or intramuscular route under the supervision of a healthcare professional. The dosage regimen should be individualized based on the patient's response to therapy and any underlying medical conditions.
Dosage Forms and Strengths: Drotaverine Hydrochloride Injection is available as a sterile solution in single-dose vials. Each mL of solution contains drotaverine hydrochloride equivalent to 20 mg of drotaverine base.
Contraindications: Drotaverine Hydrochloride Injection is contraindicated in patients with known hypersensitivity to drotaverine hydrochloride or any of the excipients. It should not be used in patients with severe hepatic impairment or in those with obstructive disorders of the gastrointestinal tract, such as paralytic ileus.
Warnings and Precautions: Caution should be exercised when administering Drotaverine Hydrochloride Injection to patients with impaired hepatic or renal function, as dose adjustments may be necessary. It should be used with caution in patients with hypotension, as it may cause a further decrease in blood pressure. The injection should be administered slowly to minimize the risk of adverse effects.
Adverse Reactions/Side Effects: Common adverse reactions associated with Drotaverine Hydrochloride Injection include dizziness, headache, nausea, vomiting, and allergic reactions such as rash or pruritus. In rare cases, it may cause hypotension or tachycardia. If any adverse reactions occur, the infusion should be discontinued, and appropriate medical treatment initiated.
Drug Interactions: Drotaverine Hydrochloride Injection may potentiate the effects of other drugs that cause smooth muscle relaxation or hypotension, such as antihypertensive agents or vasodilators. Concurrent use with drugs that inhibit cytochrome P450 enzymes, such as ketoconazole or erythromycin, may increase the serum concentration of drotaverine, leading to potential adverse effects.
Use In Specific Populations Description: The safety and efficacy of Drotaverine Hydrochloride Injection in pediatric patients, geriatric patients, and pregnant or lactating women have not been established. Use with caution in these populations, and only if the potential benefits outweigh the risks. Close monitoring is recommended in patients with renal or hepatic impairment.
How Supplied/Storage and Handling: Drotaverine Hydrochloride Injection is supplied as a sterile solution in single-dose vials. It should be stored at controlled room temperature between 20°C to 25°C (68°F to 77°F), protected from light and moisture. Do not freeze. Discard any unused portion of the solution.