Description

Composition:
Each Speedex-Spas tablet contains:
Dicyclomine                                                                           10mg
Mefenamic acid                                                                     250mg
 
Dosage form:
Tablets
 
ATC classification:
Dicyclomine- Synthetic anticholinergics
Mefenemic acid- muscular anti inflammatory, anti rheumatic non steroidal
 
Description: 
Speedex-Spas, a formulation intended to provide relief from spasms and associated pain related to smooth muscles of the body. It is a combination product having dicyclomine and mefenemic acid that work as anti-spasmodic and anti-inflammatory respectively. Dicyclomine is an anti-cholinergic drug that relieves smooth muscle spasm of the gastrointestinal tract, urinary tract and also of the pelvic region that marks its usefulness in treating IBS, anal spasms and moderate to severe spasmodic dysmenorrheal in women and adolescent teens. Mefenemic acid is a non-steroidal anti inflammatory drug that provides relief from the pain associated with the spasms. Mefenamic acid with dicyclomine is known to be a highly effective and well tolerated treatment for spasmodic dysmenorrheal.
 
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 shows direct effect on smooth muscles by antagonizing the bradykinin and histamine-induced spasms. Its direct relaxing effect on smooth muscle relieves the spasms and hence its usefulness in treating or preventing spasm of the muscles of the gastrointestinal tract in the irritable bowel syndrome, urinary tract spasms, urinary incontinence as well as spasmodic dysmenorrheal in women.
Mefenamic acid is a member of the fenamate group of nonsteroidal anti-inflammatory drugs (NSAIDs). It exhibits anti-inflammatory, analgesic, and antipyretic activities. Its anti-inflammatory activity is by inhibiting the enzyme, cyclooxygenase (COX), an early component of the arachidonic acid cascade that results in the formation of prostaglandins, thromboxanes and prostacyclin.  Prostaglandins are produced at sites of injury or damage causing pain and inflammation. Mefenamic acid by blocking the effect of COX enzymes, reduce the prostaglandin formation, which means pain and inflammation are eased. By inhibiting thromboxane synthase enzyme mefenemic acid decreases thromboxane A2, thereby inhibiting platelet aggregation.
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.
Mefenamic acid:
After oral administration mefenamic acid is rapidly absorbed, reaching peak values within 2 to 4 hours and the elimination half-life approximates 2 hours. Volume of distribution (Vd) is approximately 1.06 L/kg.  Mefenamic acid, its metabolites and conjugates are primarily excreted by the kidneys as glucuronides of mefenamic acid (6%), 3-hydroxymefenamic acid (25%) and 3- carboxymefenamic acid (21%).  The unconjugated form of 3-carboxymefenamic acid is excreted via fecal route.
 
Indications:
Speedex-Spas tablets are indicated for the following:

• Colicky pains: intestinal colic, ureteric colic, biliary colic
• Adjuvant to irritable bowel syndrome therapy
• Moderate to severe spasmodic dysmenorrheal
• Post surgical spasm

 
Dosage and Administration:
As recommended by the Physician depending on the intended use.
When prescribed for Primary dysmenorrheal that effective treatment can be initiated with the start of menses and should not be necessary for more than 2 to 3 days
Note:It is recommended to use the lowest effective dose for the shortest duration (usually not exceeding 7 days) consistent with individual patient treatment goals.
 
Contraindications:
Speedex-Spas tablets are contraindicated in patients with hypersensitivity or idiosyncrasy to any of its ingredients and NSAIDs
It is also contraindicated in the following conditions:

• Obstructive uropathy
• Obstructive disease of the gastrointestinal tract
• Severe ulcerative colitis
• Reflux esophagitis
• Glaucoma
• Myasthenia gravis
• For the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
• In patients with GI bleeding, moderate to severe renal impairment and acute porphyria
• Patients in whom aspirin or other NSAIDs, precipitate attacks of bronchospasm, urticaria or acute rhinitis
• Patients with severe heart failure, hypertension, hepatic or renal insufficiency.

 
Side effects:
Side effects reported with Speedex-spas are typically anticholinergic in nature and also those reported with use of NSAIDs:
Sedation, drowsiness, blurred or double vision, nausea, heartburn, diarrhea, headache, dizziness, fluid and salt retention, edema feet, high blood pressure, flatulence, constipation, abdominal pain and loss of appetite.
Note:
Discontinue use if any hypersensitivity reactions such as rash or redness occur.
Patients should immediately report signs or symptoms of unexplained weight gain or edema to their physicians.
 
Warnings and Precautions:
General:

• Investigate any tachycardia before administration of Speedex-spas, since dicyclomine may increase the heart rate.
• Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with dicyclomine containing formulation would be inappropriate and possibly harmful.
• Psychosis has been reported in sensitive individuals given anticholinergic drugs (dicyclomine). CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, decreased anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug.
• Speedex-spas should be used with caution in patients with Autonomic neuropathy, Cardiac tachyarrhythmia, Hiatal hernia, known or suspected prostatic hypertrophy.
• Speedex-spas should be used with caution in patients with fluid retention or congestive heart failure and other related cardio vascular conditions.
• Speedex-spas might increase the risk of serious cardiovascular events or intestinal bleeding. Ensure that you fully discuss the potential risks with your physician before beginning treatment.
• If you suffer from liver disease and gastrointestinal disorders, ensure that you make your physician aware of this before treatment begins, in order for your physician to determine whether or not this medicine is safe and suitable for you.
• Precaution to be exercised in patients with: Gastrointestinal bleeding, history of peptic ulceration, cerebrovascular bleeding, ulcerative colitis, Crohn’s disease, systematic lupus erythromatosus (SLE), porphyria, hematopoietic or coagulation disorders, Raynaud’s phenomenon.
• Patients should be instructed to stop therapy and seek immediate medical therapy if they observe warning signs and symptoms of hepatotoxicity (e.g. nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms)
• Long term use of NSAIDs is likely to cause renal damage.
• Mefenamic acid containing medications are to be avoided in women attempting to conceive and also in women who are undergoing investigation of infertility

Drug Interactions:

• 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)
• narcotic analgesics (e.g., meperidine)
• nitrates and nitrites
• benzodiazepines
• MAO inhibitors
• sympathomimetic agents
• tricyclic antidepressants
• Other drugs having anticholinergic activity.
• Dicyclomine is known to antagonize the effects of antiglaucoma agents and also the effects of drugs that alter gastrointestinal motility, such as metoclopramide
• Antacids may interfere with the absorption of dicyclomine therefore simultaneous use of antacids and dicyclomine containing medication should be avoided.
• Mefenamic acid (NSAID) may increase the plasma concentrations of lithium & digoxin. Simultaneous use of NSAIDs & diuretics may inhibit the activity of diuretics. The activity of anticoagulants may be enhanced when used in conjuction with NSAIDs. They may increase toxicity of drugs like cyclosporine. NSAIDs may diminish anti-hypertensive action of ACE-inhibitors.

Pregnancy and Lactation:
Speedex-Spas tablets are contraindicated in pregnancy and lactation.
Pediatric use:
Safety and effectiveness of Speedex-spas in pediatric patients below the age of 14 have not been established.
 
References:
Dicyclomine
https://pubchem.ncbi.nlm.nih.gov/compound/dicyclomine#section=Human-Metabolite-Information
Mefenamic acid
https://pubchem.ncbi.nlm.nih.gov/compound/mefenamic_acid#section=Absorption-Distribution-and-Excretion
https://www.fda.gov/
 
 
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.