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Not to be sold by retail without the prescription of a Registered Medical Practitioner
Prescribing Information
1. Generic Name
Dicyclomine Hydrochloride & Simethicone Suspension
(Brand Name: MEFTAL-SPAS®^ Drops)
2. Qualitative and Quantitative Composition
Each ml (approx. 20 drops) contains: Dicyclomine Hydrochloride IP ……………………………………………… 10 mg Simethicone Emulsion USP eq. to Simethicone ….………………..………… 40 mg Flavoured syrup base ……………………………………………………….….. q.s. Colour: Sunset Yellow FCF.
3. Dosage Form and Strength
Dosage Form: Oral liquid (Suspension). Dosage Strength: Dicyclomine 10 mg with Simethicone 40 mg per ml.
4. Clinical Particulars
4.1 Therapeutic Indications
MEFTAL-SPAS Drops are used for the relief of infantile colic, gastrointestinal tract (GI) spasm, flatulence and abdominal discomfort due to excess gas formation in disorder such as dyspepsia and gastro-esophageal reflux disease (GERD).
4.2 Posology and Method of Administration
For oral administration in infants and children between 6 months to 2 years of age: 0. to 1 ml (approximately 10 to 20 drops) to be administered 3 to 4 times a day. Or, as directed by the physician.
4.3 Contraindications
MEFTAL-SPAS Drops are contraindicated in the following: Known hypersensitivity to dicyclomine or to simethicone or to any excipient of the formulation. Infants under 6 months of age. Breast-feeding women. Obstructive uropathy. Obstructive disease of the GI tract. Severe ulcerative colitis. Reflux esophagitis. Unstable cardiovascular status in acute hemorrhage. Glaucoma.
Myasthenia gravis.
4.4 Special Warnings and Precautions for Use
Dicyclomine Hydrochloride General: Products containing dicyclomine hydrochloride 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 esophagitis because anticholinergic drugs may aggravate the condition. Peripheral and Central Nervous System (CNS): The peripheral effects of dicyclomine hydrochloride are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system. They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation. Cardiovascular Conditions: Dicyclomine hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure, and in cardiac surgery, where they may further accelerate the heart rate. Investigate any tachycardia before administration of dicyclomine hydrochloride. Care is required in patients with coronary heart disease (as ischemia and infarction may be worsened) and in patients with hypertension. Hepatic and Renal Disease: Should be used with caution in patients with known hepatic and renal impairment.
Simethicone No special warnings and precautions are needed. Simethicone is apparently non-toxic; no adverse effects reported.
4.5 Drug Interactions
Dicyclomine Hydrochloride Anti-glaucoma agents: Anticholinergics antagonize the effects of anti-glaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. Use of dicyclomine in patients with glaucoma is not recommended. Other drugs with anticholinergic activity: The following agents may increase certain actions or side effects of anticholinergic drugs including dicyclomine: Amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, monoamine oxidase (MAO) inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity.
4.7 Effect on Ability to Drive and Use Machines
Dicyclomine content of this formulation may produce drowsiness, dizziness or blurred vision. Thus, patients should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking this formulation.
4.8 Undesirable Effects
Dicyclomine Hydrochloride Side-effects seldom occur with dicyclomine. However, in susceptible individuals, the following adverse effects have been reported: Gastrointestinal disorders: Abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting. General disorders and administration site conditions: Fatigue, malaise. Immune system disorders: Drug hypersensitivity including face edema, angioedema, anaphylactic shock. Cardiac disorders: Palpitations, tachyarrhythmias. Eye disorders: Cycloplegia, mydriasis, blurred vision. Nervous system disorders: Dizziness, headache, hallucinations, insomnia, somnolence, syncope. Psychiatric disorders : Confusional state, nervousness. Reproductive system and breast disorders: Suppressed lactation. Respiratory, thoracic, and mediastinal disorders: Dyspnea, nasal congestion. Skin and subcutaneous tissue disorders: Allergic dermatitis, erythema, rash.
Simethicone Simethicone may cause diarrhoea, nausea, vomiting, and headache. Seek immediate medical attention if any of the following allergic symptoms/reactions occur: Hives; difficulty breathing; swelling of face, lips, tongue, or throat.
4.9 Overdose
Dicyclomine Hydrochloride Symptoms of dicyclomine overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). Treatment should consist of gastric lavage, emetics, and activated charcoal. Sedatives (barbiturates/benzodiazepines) may be used for management of overt signs of excitement. If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.
Simethicone Simethicone is apparently nontoxic; no adverse effects reported. Seek emergency medical attention in case of overdose.
5. Pharmacological Properties
5.1 Mechanism of Action
Dicyclomine Hydrochloride Antispasmodic action of dicyclomine is achieved via a dual mechanism:
- A specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately ⅛th^ the milligram potency of atropine.
- A direct spasmolytic effect upon smooth muscles (musculotropic) of intestine, bile duct, ureters, and uterus.
Simethicone Simethicone produces anti-flatulent effect by decreasing the surface tension of gas bubbles, causing them to combine into larger bubbles in the stomach. The gas bubbles are then broken or coalesced and in this form, the gas is more easily eliminated through belching or passing flatus.
5.2 Pharmacodynamic Properties
Dicyclomine Hydrochloride Dicyclomine is an anti-spasmodic and anti-muscarinic agent. Dicyclomine relieves smooth muscle spasm of the GI, biliary, and ureteric tracts.
Simethicone Simethicone is an anti-flatulent agent. Simethicone does not reduce the quantity of gas in the digestive tract, it only increases the rate at which it exits the body. Simethicone does not prevent the formation of gas from swallowed air or from being created by intestinal bacteria.
5.3 Pharmacokinetic Properties
Dicyclomine Hydrochloride Dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60 to 90 minutes. Mean volume of distribution for a 20 mg oral dose of dicyclomine is approximately 3.65 l/kg, suggesting extensive tissue penetration. The principal route of elimination of dicyclomine is via the urine (79.5% of the dose). Excretion also occurs in the feces, but to a lesser extent (8.4%). There are two phases of elimination, the first with a shorter half-life of 1.8 hours, and a second phase with a longer half-life.
Simethicone Simethicone is locally acting and is not absorbed. It is eliminated unchanged in feces.
6. Nonclinical Properties
6.1 Animal Toxicology
Dicyclomine Hydrochloride
Inactive ingredients (excipients) of MEFTAL-SPAS Drops contains Methyl Paraben, Propyl Paraben, Citric Acid Monohydrate, Indion 234, Sucrose, Xanthan Gum, Saccharin Sodium, Propylene Glycol, Colloidal Silicon Dioxide, Flavour Liquorice ASV, Menthol, Colour Sunset Yellow supra, and Purified Water.
8. Pharmaceutical Particulars
8.1 Incompatibilities
None known.
8.2 Shelf-life
24 months.
8.3 Packaging Information
10 ml bottle with dropper.
8.4 Storage and Handling Instructions
Store at a temperature not exceeding 30°C. Protect from light. Keep out of reach of children.
9. Patient Counseling Information
Administration Instructions Instruct patients/caregivers to ensure the prescribed dose of MEFTAL-SPAS Drops is taken as directed. Shake well before each use. Instruct patients/caregivers to use this product with caution during pregnancy (due to lack of safety data). Further, breastfeeding women should not use this medicine during lactation. If drug therapy is essential, breast-feeding must be discontinued during treatment period. Instruct users not to expose themselves with high temperature conditions as decreased sweating, fever and heat stroke can occur with this medicine (dicyclomine). If symptoms occur, the drug should be discontinued and contact doctor immediately. This drug may produce drowsiness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating machinery or driving vehicle while on therapy.
10.Details of Manufacturer
M/s. Hema Laboratories Pvt. Ltd. Plot No. 29, Pharmacity, Selaqui Industrial Area,
Dehradun – 248 011, Uttarakhand, India.
11. Details of Permission or License Number with Date
DCG(I) NOC date: 16th^ September 2016. Manufacturing license No. 19/UA/2007. Date of Product Permission 29th^ September 2009.
12. Date of Revision
January 2021.
