Product Code : SP-05B
PACK : – 15 Vial
COMPOSITION: Each ml contain: Dicyclomine HCl IP 10 mg \ Chlorbutol IP 0.5 % w/v (As Preservative) Water for Injections IP qs
Dosage Form :Vial
SP-05B:
INFORMATION FOR THE USER
Dicyclomine Injection
Read all of this information carefully before you start taking this medicine because it contains important information for you.
• Keep this information. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.
1. COMPOSITION:
Eachml ampoule contains:
Dicyclomine HCl IP – 10mg
Benzyl alcohol IP (As preservative) – 2% v/v
For IM use only.
2. DESCRIPTION:
Dicyclomine is an antispasmodic and helps relieve smooth muscle spasms.
3. PHARMACOLOGICAL ACTION:
Dicyclomine relieves smooth muscle spasm of the GI tract. Studies indicate that this action is achieved via a dual mechanism:
– a specific anticholinergic effect (antimuscarinic at the ACh-receptor sites)
– a direct effect upon smooth muscle (musculotropic)
4. CLINICAL PHARMACOKINETICS:
After a single oral 20mg dose peak plasma conc. reached a mean value of 58ng/ml in 1-1.5 hrs. 14C labelled studies demonstrated comparable bioavailability from oral &IV administration. The principal route of elimination is via the urine.
5. INDICATIONS:
Dicyclomine injection is indicated for the treatment of:
– Irritable bowel syndrome
6. CONTRAINDICATIONS:
– Hypersensitivity to the active substance or to any of the excipients.
7. WARNINGS AND PRECAUTIONS:
Should be used with caution in any patient with or suspected of having glaucoma or prostatic hypertrophy.
Use with care in patients with hiatus hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate the condition.
8. ADVERSE EFFECTS:
Common side effects include: Dry mouth, Thirst & dizziness may occur. On rare occasions Fatigue, Sedation, Blurred vision, Rash, Constipation, Anorexia, Nausea & vomiting, Headache & Dysuria may occur.
9. DRUG INTERACTIONS:
None known.
10. DOSAGE:The usual dosage is 10-20mg IM every 6 hours. Not to exceed 80mg/day IM.
11. ADMINISTRATION:
For IM use only.
Administration to be done by a registered medical practitioner/nurse in a proper sterile and hospital setting only.
12. STORAGE:
Do not store above 25°C. Store in the original package. Keep away from children. Do not expose to direct sunlight.
13. MANUFACTURED BY:
14. MARKETED BY:
Last revised on August 2020.