INTRODUCTION

DROTAM INJECTION contains Drotaverine which belongs to the group of medicines called Antispasmodic agents. It is used in the treatment of spastic condition (abnormal stiffness) of smooth muscles in the urinary tract (nephrolithiasis, pyeitis), biliary tract diseases (cholecystolithiasis, cholecystitis, cystitis, vesical tenesmus) and as an adjunctive in gastrointestinal tract (gastric and duodenal ulcer disease, cardia and pylorus of stomach, irritable bowel syndrome, spastic constipation, flatulence) and reproductive tract (dysmenorrhea).  

Your doctor may recommend you to take relevant tests to understand your existing condition. DROTAM INJECTION is not recommended for use in patients with severe liver, kidney or heart disease and porphyria (blood disorder).

Before receiving DROTAM INJECTION inform your doctor if you have low blood pressure, fits or seizure disorder, kidney or liver impairment and suffering from alcoholism. DROTAM INJECTION should be used with caution in pregnant women only if advised by the doctor.  

DROTAM INJECTION is not recommended for use in breastfeeding women. DROTAM INJECTION is not recommended for use in children under 12 years of age. This medicine may cause side effects such as nausea, constipation, headache, dizziness and injection site reactions such as reddening, pain and edema. Inform your doctor if any of the side effect worsens.

USES OF DROTAM INJECTION

• Treats spastic condition of smooth muscles in the urinary tract, biliary tract diseases and as an adjunctive in gastrointestinal tract and reproductive tract

HOW DROTAM INJECTION WORKS

DROTAM INJECTION works by blocking certain enzymes, which results in increased release of chemical substance that causes relaxation of smooth muscles. This kind of action provides relief from spastic condition by relieving the contraction of smooth muscles.

DIRECTIONS FOR USE

DROTAM INJECTION will be given to you only by a doctor or a nurse into a vein as an intravenous injection or into muscles as an intramuscular injection or under the skin as subcutaneous injection. Your doctor will decide the dose, duration of the treatment and frequency depending upon your age and condition.

SIDE EFFECTS OF DROTAM INJECTION

HOW TO MANAGE SIDE EFFECTS

Nausea:

Take regular sips of a cold drink. Have ginger or peppermint tea. Stick to simple meals. Avoid eating oily or spicy foods. Inform your doctor if the symptom does not improve.

Constipation:

Take fiber rich foods in your diet such as fresh fruits, vegetables, whole grain cereals and drink plenty of fluids. Exercise more regularly and stay active. Inform your doctor if the symptom does not improve. 

Headache:

Drink ample amount of water. Get adequate rest. Try to be relaxed and stress free. Ask your doctor before taking any medicine for headache. Inform your doctor if the symptom does not improve. 

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before receiving DROTAM INJECTION, inform your doctor if you are taking any of the following medicines:

• levodopa (used to treat Parkinson's disease)
• papaverine (used to treat the symptoms of arterial spasm)

Overdosage:

DROTAM INJECTION will be given to you only by a doctor or nurse in a hospital, and so it is unlikely to receive an overdose. However, if you experience any unusual symptoms consult your doctor immediately.

SYNOPSIS

MORE INFORMATION

• Store at room temperature

FAQs ABOUT DROTAM INJECTION

Q: What happens when you forget to receive DROTAM INJECTION?

A: DROTAM INJECTION will be given to you only by a doctor or nurse in a hospital, and so it is unlikely for you to miss the dose. Consult your doctor for more information on dosage and duration of the treatment.

Q: How does DROTAM INJECTION work?

A: DROTAM INJECTION works by blocking certain enzymes, which results in increased release of chemical substance that causes relaxation of smooth muscles. This kind of action provides relief from spastic condition by relieving the contraction of smooth muscles. 

Q: Can DROTAM INJECTION be used in pregnant women?

A: DROTAM INJECTION should be used with caution in pregnant women or women planning to have a baby only if the potential benefit to the mother outweighs the risk to which the fetus is exposed as it may cross the placenta. Consult your doctor for advice.

Q: Is DROTAM INJECTION safe for use in patients with liver disease?

A: DROTAM INJECTION is not recommended for use in patients with severe liver disease. It should be used with caution in patients with liver disease or liver impairment. Consult your doctor before receiving DROTAM INJECTION.  

Q: Can DROTAM INJECTION be used in patients with kidney disease?

A: DROTAM INJECTION is not recommended for use in patients with severe kidney disease. It should be used with caution in patients with kidney impairment. Consult your doctor before receiving DROTAM INJECTION.

REFERENCES

1. KD. Tripathi. Anticholinergic drugs and drugs acting on autonomic ganglia. Essentials of medical pharmacology. 8th Edition. 2019. Page – 129

2. Ramesh R. Rai, Manisha Dwivedi, and Nirmal Kumar. Efficacy and Safety of Drotaverine Hydrochloride in Irritable Bowel Syndrome: A Randomized Double-Blind Placebo-Controlled Study. NIH National Library of Medicine, National center for biotechnology information. Pubmed central. 2014 [Accessed on 11th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4271014/

3. Ramesh R. Rai and Sandeep Nijhawan. Comparative evaluation of efficacy and safety of drotaverine versus mebeverine in irritable bowel syndrome: A randomized double-blind controlled study. NIH National Library of Medicine, National center for biotechnology information Pubmed Central 2021 [Accessed on 11th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8265406/

4. Profarma Sh.a. Drotaverine. [Revised in May 2013] [Accessed on 11th July 2022] http://www.profarma.al/index.php/products/products-menu-group/new-products/product/36-drotaverine-2

5. Indus pharma Pvt Ltd. Drotaverine injection. [Accessed on 11th July 2022] https://induspharma.in/products-list/drotaverine-injection /

USEFUL DIAGNOSTIC TESTS

• Liver function test
• Kidney function test