Description

Composition:
Each ml contains
Dicyclomine HCL USP 10mg
Simethicone USP 40mg
 
Dosage form:
Oral drops
 
ATC classification:
Anti cholinergic and anti foaming
 
Description: 
Speedex-P oral drops formulated for infants is to provide relief from spasms of gastrointestinal tract and also facilitate the gas dispersion without any constipation. It provides the infant symptomatic relief from griping pain and colic. Dicyclomine present in Speedex-P drops is an anti-cholinergic drug that works as anti spasmodic by relaxing the smooth muscle spasm and cramps of the gastrointestinal tract, biliary and urinary tract. Simethicone present in Speedex-P drops relieves the infant of the painful pressure caused by excess gas in the stomach and intestines especially in breast feeding babies where they inhale air along with the milk. This formulation does not induce sedation or constipation.
 
Pharmacological action:
Dicyclomine antagonizes the action of a neurotransmitter acetylcholine, a chemical released from nerves that stimulates muscles. It reduces the effect of acetylcholine by blocking the receptors for acetylcholine on smooth muscle, a type of muscle located in walls of stomach, intestines, gallbladder, urinary Bladder, airways to the lungs and uterus. Dicyclomine also has direct effect on smooth muscles by antagonizing the bradykinin and histamine-induced spasms. It has a direct relaxing effect on smooth muscle and therefore relieves the spasms in the smooth muscles and hence its usefulness in treating or preventing spasm of the muscles of the gastrointestinal tract, urinary tract and biliary tract.
Simethicone decreases the surface tension of gas bubbles, thus facilitating their coalescence and easier expulsion of gas as flatus or belching. It allows mucus-surrounded gas bubbles in the stomach and intestinal tract to coalesce and pass through bowel lumen to get excreted in greater volume at one time. By this simethicone reduces the excess gas that causes uncomfortable or painful pressure in the stomach and intestines. However, simethicone does not prevent the formation of the gas.
Pharmacokinetics:
Dicyclomine:
After oral administration it is rapidly absorbed, reaching peak values within 60- 90 minutes with %) with half-life of plasma elimination of around 1.8hours. Renal excretion eliminates 79.5% of the administered dose and the rest is excreted via feces. Volume of distribution (Vd) for 20mg dose is approximately 3.65 L/kg which indicates an extensive distribution in tissues.
Simethicone:
Simethicone is pharmacologically inert and neither it is absorbed from the gastrointestinal tract nor does it interfere with gastric secretion or absorption of nutrients. However it may show drug-drug interactions. Following oral administration, Simethicone is excreted in faces unchanged.
 
Indications:
Speedex-P is indicated for
¬ For symptomatic relief of infantile colic (a form of pain which starts and stops abruptly) commonly occurring in breast-fed infants.
¬ Providing prompt relief from all spasmodic pain
¬ Intestinal colicky pain
¬ Abdominal pain due to gastric spasm
¬ Colicky pains: intestinal colic, ureteric colic, biliary colic
 
Dosage and Administration:
Note:
¬ Speedex-P oral drops should be used only under the supervision of a qualified doctor.
¬ Dicyclomine is contraindicated in infants aged 6 months and under
The recommended dosage unless otherwise specified by the doctor
• Infant(6months-1year): 0.5 ml orally 3-4 times daily
• Children (1- 11/2 year): 1ml-5ml orally 3-4 times daily.
• Children ( 11/2-12 years): 10ml 3-4 times a day
All doses are to be administered 15minutes before feed.
 
Contraindications:
¬ Speedex P oral drops are contraindicated in patients with hypersensitivity or idiosyncrasy to either dicyclomine or simethicone
¬ Speedex-P oral drops are contraindicated in known or suspected intestinal perforation and obstruction
¬ They are also contra-indicated in myasthenia gravis paralytic ileus, pyloric stenosis, and toxic megacolon.
 
Side effects:
Occasional side effects with Speedex P oral drops are: nausea, vomiting, and giddiness
Much less reported side effects are: constipation, transient bradycardia (followed by tachycardia, palpitation and arrhythmias), urinary urgency and retention, reduced bronchial secretions, dilatation of the pupils with loss of accommodation, photophobia, dry mouth, flushing and dryness of the skin
Very rare side effects: angle closure glaucoma.
 
Warnings and Precautions:
General:
¬ Speedex-P oral drops are contraindicated in infants aged 6 months and under.
¬ Speedex-P should be used with caution in patients with abdominal pain of unknown cause, especially when accompanied by fever.
¬ Do not exceed recommended dosage. It is advisable to calculate the dose not only on basis of age but also weight of the infant.
¬ Assess the patient for abdominal pain, distention, and bowel sounds prior to prescribing and also periodically throughout course of therapy. Frequency of belching and passage of flatus should also be assessed.
¬ Dicyclomine present in Speedex-P is an anticholinergic drug may cause psychosis in individuals sensitive to CNS drugs. Discontinue use and immediately report to doctor if any of these signs and symptoms are seen: confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, decreased anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.
Drug Interactions:
¬ Antacids may interfere with the absorption of dicyclomine therefore simultaneous use of these drugs should be avoided
¬ The following agents may increase certain actions or side effects associated with diyclomine (anti-cholinergic):
Amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity.
¬ Dicyclomine may antagonize the effects of antiglaucoma agents and also the effects of drugs that alter gastrointestinal motility, such as metoclopramide
¬ Drug-drug interactions are to be thoroughly assessed before prescribing concomitant use of other medications with Speedex-P
Pediatric use:
Speedex-P oral drops are contraindicated in infants aged 6 months and under.
 
References:
Dicyclomine
https://pubchem.ncbi.nlm.nih.gov/compound/dicyclomine#section=Human-Metabolite-Information
Simethicone
https://pubchem.ncbi.nlm.nih.gov/compound/Simethicone
 
Disclaimer:
Information provided above is for reference purpose only and has been compiled for use by healthcare practitioners. Please consult your physician to understand how the product affects you, its dosages, side-effects and further information.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indications prescribed by your physician.
Every effort has been made to ensure that the information provided by Pharma Synth Formulations Ltd. (‘PSFL’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. PSFL does not endorse drugs, diagnose patients or recommend therapy and is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. PSFL does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.