Botropase Injection

BOTROPASE INJECTION by JUGGAT PHARMA

Botropase Injection is a potent haemostatic agent manufactured by Juggat Pharma, used to control and prevent bleeding.

Composition

Botropase Injection contains Haemocoagulase (1 CU) isolated from the venom of Bothrops atrox or Bothrops jararaca snakes. It also contains Sodium Chloride IP 0.9% w/v and Phenol IP 0.3% w/v as a preservative.

Uses

Botropase Injection is prescribed for managing various bleeding conditions and controlling hemorrhage. Its uses include:

• Bleeding Disorders: Helps manage conditions affecting normal blood clot formation.
• Surgical Bleeding: Effective in controlling bleeding during and after various surgeries, such as tooth extraction, cleft-palate surgery, skin grafting procedures, ENT surgeries (adenoidectomy, tympanoplasty, tonsillectomy), and haemorrhoidectomy.
• Internal and External Haemorrhages: Used for pulmonary bleeding, traumatic bleeding, postoperative bleeding, oral bleeding, and gastrointestinal bleeding.
• Gynecological Bleeding: Addresses conditions like Postpartum Hemorrhage (PPH), Abnormal Uterine Bleeding (AUB), Dysfunctional Uterine Bleeding (DUB), post-aborted bleeding, menorrhagia, and metrorrhagia.
• Neonatal Pulmonary Haemorrhage.
• Manages post-extraction bleeding in cardiac patients taking aspirin without discontinuing the aspirin.

Dosage and Administration

Botropase Injection should be administered by a healthcare professional, either intramuscularly (IM) or intravenously (IV). Self-administration is not recommended. The exact dosage and duration of treatment depend on the severity of the condition and the patient's response.

• Prophylactic Dosage (before surgery): Typically 1 ml IM 30 minutes to 1 hour before surgery, and/or 1 ml IV 15 to 30 minutes prior to surgery. For preventing postoperative hemorrhage due to coagulopathies, 1 ml IM daily for 3 to 4 days before surgery may be given.
• Therapeutic Dosage: 1 ml IM or IV, repeated every 6 to 8 hours until the desired effect is obtained. In emergencies, IV injection can be followed by IM, and the injection may be repeated every 30 minutes until the desired response is achieved.

Side Effects

Common side effects of Botropase Injection may include:

• Allergic reactions (rash, itching, difficulty breathing).
• Redness, swelling, or discomfort at the injection site.
• Dizziness or lightheadedness.

Serious but rare side effects can include severe allergic reactions, abnormal blood clot formation, chest pain, difficulty breathing, or swelling in the legs. Seek immediate medical attention if any severe or persistent side effects occur.

Precautions

• Allergies: Do not take this medicine if you have known allergies to haemocoagulase or similar medications.
• Clotting Disorders: Contraindicated in individuals with pre-existing clotting disorders such as arterial and venous thrombosis, embolism, or disseminated intravascular coagulation (DIC). It can increase the risk of abnormal clots.
• Pregnancy and Breastfeeding: Consult a doctor before use, as safety during pregnancy and breastfeeding has not been established.
• Liver and Kidney Disease: Use with caution in patients with severe liver or kidney problems; close monitoring may be required.
• Alcohol: Avoid consuming alcohol while using Botropase Injection, as it may increase the risk of side effects.
• Underlying Medical Conditions: Inform your healthcare provider about any underlying medical conditions, especially severe hypertension, Von Willebrand disease, haemophilia, or cardiac and vascular disorders.
• Special Populations: Use with caution in elderly or pediatric populations and in those with chronic viral diseases like HIV or hepatitis.

Storage

Store Botropase Injection in a cool and dry place, ideally below 25°C. Protect the medicine from direct sunlight, as it can affect its potency. Ensure it is stored out of reach of children. Always check the expiry date before use.

BOTROPASE INJECTION by JUGGAT PHARMA is a haemostatic agent used to control bleeding. It contains Haemocoagulase, an enzyme derived from snake venom, which promotes blood clotting.

Here are some frequently asked questions about Botropase Injection:

What is Botropase Injection used for?

Botropase Injection is primarily used to manage bleeding disorders and control bleeding during various medical and surgical procedures. This includes bleeding after tooth extractions, during cleft-palate surgery, skin grafting, and other internal and external hemorrhages. It is also used in patients with haemophilia to reduce post-extraction bleeding and can help manage bleeding in cardiac patients taking aspirin without discontinuing the aspirin.

How does Botropase Injection work?

The active ingredient in Botropase Injection is haemocoagulase, which is derived from the venom of Bothrops Jararaca or Bothropsatrox snakes. It works by accelerating the blood clotting process. Haemocoagulase converts fibrinogen into fibrin, essential components for forming blood clots. It also promotes platelet clumping, reduces capillary permeability at the site of injury, increases thromboplastic activity, and reinforces Factor XIII A, thereby minimizing blood loss.

What is the usual dosage of Botropase Injection?

Botropase Injection is typically administered as 1 ml (containing 1 KU of haemocoagulase) via intramuscular or intravenous injection. The dosage and frequency depend on the clinical situation, patient's weight, age, and underlying conditions. For surgical procedures, it may be given 30 minutes to an hour before surgery. In cases of ongoing hemorrhage, the dose may be repeated every 4-8 hours as needed, but the maximum daily dose should not exceed 4-5 ml (or 4-5 KU). It should always be administered by a healthcare professional.

What are the possible side effects of Botropase Injection?

Common side effects may include allergic reactions, redness, swelling, or pain at the injection site, and dizziness. Serious but rare side effects can include severe allergic reactions, blood clot formation, chest pain, difficulty breathing, or swelling in the legs. If any severe or persistent side effects occur, immediate medical attention should be sought.

Is Botropase Injection safe during pregnancy or breastfeeding?

The safety of Botropase Injection during pregnancy has not been established, and it is generally not recommended unless deemed necessary by a doctor, who will discuss the risks and benefits. Similarly, it is not known whether the medication passes into breast milk, so it is advisable to consult your doctor before using it if you are breastfeeding.

Can Botropase Injection be taken with other medications?

Botropase Injection can interact with several other medications. It should be used with caution with anticoagulants (such as warfarin and heparin), nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, platelet aggregation inhibitors (like aspirin and clopidogrel), and thrombolytics (such as alteplase and reteplase). It also interacts with Reserpine, Sulfadimethoxine, and Testosterone. It is crucial to inform your doctor about all your current medications, including any herbs and supplements, before receiving Botropase Injection.

What precautions should be taken with Botropase Injection?

Botropase Injection should not be self-administered. It should be used with caution in individuals with a history of bleeding disorders, liver or kidney disease, or hypercoagulable states. It is contraindicated in patients with existing clotting disorders such as thrombosis, embolism, or disseminated intravascular coagulation (DIC). Hypersensitivity testing should be performed before administration. Alcohol consumption should be avoided as it may increase the risk of side effects. Safety and effectiveness in children have not been fully established, and it should be used with caution in the elderly.

What happens if a dose of Botropase Injection is missed?

If a dose of Botropase Injection is missed, it is important to contact your healthcare provider for guidance on how to proceed. It is crucial not to double up on doses to compensate for a missed one without first consulting your doctor.

How should Botropase Injection be stored?

Botropase Injection should be stored in a cool and dry place, away from direct sunlight. It should be kept out of the reach of children. Always check the expiry date before using the product to ensure its effectiveness.