Consists of dicyclomine, mefenamic acid
Actions of Dicyclomine (Mefrag-SPAS) in details
Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism:
- a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine (in vitro, guinea pig ileum); and
- a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine's antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum.
Atropine did not affect responses to these two agonists. In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl2)-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl2. Tests for mydriatic effects in mice showed that dicyclomine was approximately 1/500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1/300 as potent as atropine.
How should I take Dicyclomine (Mefrag-SPAS)?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Dicyclomine (Mefrag-SPAS) oral is taken by mouth.
Measure liquid medicine with the supplied syringe or a dose-measuring device (not a kitchen spoon).
Dicyclomine (Mefrag-SPAS) injection is given in a muscle if you are unable to take the medicine by mouth.
Call your doctor if your symptoms do not improve after 2 weeks.
Store at room temperature away from moisture and heat.
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Dicyclomine (Mefrag-SPAS) administration
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Dicyclomine is usually taken 4 times each day. Your doctor may occasionally change your dose to make sure you get the best results.
Take this medicine with a full glass of water.
Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Talk with your doctor if your symptoms do not improve after 2 weeks of treatment.
Store at room temperature away from moisture and heat.
Dicyclomine (Mefrag-SPAS) pharmacology
Mechanism Of Action
Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism:
- a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine (in vitro, guinea pig ileum); and
- a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine's antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum.
Atropine did not affect responses to these two agonists. In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl. Tests for mydriatic effects in mice showed that dicyclomine was approximately 1/500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1/300 as potent as atropine.
Pharmacodynamics
Dicyclomine (Mefrag-SPAS) can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.
Pharmacokinetics
Absorption And Distribution
In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60-90 minutes. Mean volume of distribution for a 20 mg oral dose is approximately 3.65 L/kg suggesting exentsive distribution in tissues.
Elimination
The metabolism of dicyclomine was not studied. The principal route of excretion is via the urine (79.5% of the dose). Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life.
Clinical Studies
In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times daily) demonstrated a favorable clinical response compared with 55% treated with placebo (p<0.05).
Actions of Mefenamic acid (Mefrag-SPAS) in details
Mefenamic acid (Mefrag-SPAS), an anthranilic acid derivative, is a nonsteroidal anti-inflammatory agent (NSAIA) which is structurally and pharmacologically related to meclofenamate sodium.
Mefenamic acid (Mefrag-SPAS) has anti-inflammatory, analgesic and antipyretic actions, which appear to be associated with the inhibition of prostaglandin synthesis. Like other NSAIAs, Mefenamic acid (Mefrag-SPAS) inhibits the synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase, an enzyme that catalyzes the formation of prostaglandin precursors (endoperoxides) from arachidonic acid. Unlike most other NSAIAs, the fenamates including Mefenamic acid (Mefrag-SPAS) in Mefenamic acid (Mefrag-SPAS), appear to compete with prostaglandins for binding at the prostaglandin receptor site and thus potentially affect prostaglandins that have already been formed.
The anti-inflammatory effect of Mefenamic acid (Mefrag-SPAS) is due to inhibition of prostaglandin synthesis and release during inflammation.
The analgesic effect of Mefenamic acid (Mefrag-SPAS) may involve central as well as peripheral mechanisms. Prostaglandins appear to sensitize pain receptors to mechanical stimulation and to other chemical mediators (eg, bradykinin, histamine). The analgesic effect of Mefenamic acid (Mefrag-SPAS) is due to its inhibitory action on the synthesis of prostaglandins and the effects of prostaglandins that have already been formed. Furthermore, the anti-inflammatory effect of Mefenamic acid (Mefrag-SPAS) may contribute to its analgesic effect.
Mefenamic acid (Mefrag-SPAS) lowers body temperature in patients with fever. The antipyretic effect is most likely due to the suppression of prostaglandin synthesis in the central nervous system (probably in the hypothalamus).
How should I take Mefenamic acid (Mefrag-SPAS)?
For safe and effective use of Mefenamic acid (Mefrag-SPAS), do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of Mefenamic acid (Mefrag-SPAS) may increase the chance of unwanted effects, especially in elderly patients.
Mefenamic acid (Mefrag-SPAS) should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
To lessen stomach upset, you may take Mefenamic acid (Mefrag-SPAS) with food unless your doctor tells you otherwise.
Dosing
The dose of Mefenamic acid (Mefrag-SPAS) will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Mefenamic acid (Mefrag-SPAS). If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For menstrual cramps:
- Adults and children over 14 years of age—At first, 500 milligrams (mg), then 250 mg every six hours as needed, usually for up to two to three days.
- Children up to 14 years of age—Use and dose must be determined by your doctor.
- For mild to moderate pain:
- Adults and children over 14 years of age—At first, 500 milligrams (mg), then 250 mg every six hours as needed, usually for not more than one week.
- Children up to 14 years of age—Use and dose must be determined by your doctor.
- For menstrual cramps:
Missed Dose
If you miss a dose of Mefenamic acid (Mefrag-SPAS), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Mefenamic acid (Mefrag-SPAS) administration
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
If you take Mefenamic acid (Mefrag-SPAS) for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.
Store Mefenamic acid (Mefrag-SPAS) at room temperature, away from moisture, heat, and light.
Mefenamic acid (Mefrag-SPAS) pharmacology
Pharmacodynamics
Mefenamic acid (Mefrag-SPAS) (Mefenamic acid (Mefrag-SPAS)) is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of Mefenamic acid (Mefrag-SPAS) (Mefenamic acid (Mefrag-SPAS)), like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.
Pharmacokinetics
Absorption
Mefenamic acid (Mefrag-SPAS) is rapidly absorbed after oral administration. In two 500-mg single oral dose studies, the mean extent of absorption was 30.5 mcg/hr/mL (17%CV).
Race
Pharmacokinetic differences due to race have not been identified.
Hepatic Insufficiency
Mefenamic acid (Mefrag-SPAS) pharmacokinetics have not been studied in patients with hepatic dysfunction. As hepatic metabolism is a significant pathway of Mefenamic acid (Mefrag-SPAS) elimination, patients with acute and chronic hepatic disease may require reduced doses of Mefenamic acid (Mefrag-SPAS) (Mefenamic acid (Mefrag-SPAS)) compared to patients with normal hepatic function.
Renal Insufficiency
Mefenamic acid (Mefrag-SPAS) pharmacokinetics have not been investigated in subjects with renal insufficiency. Given that Mefenamic acid (Mefrag-SPAS), its metabolites and conjugates are primarily excreted by the kidneys, the potential exists for Mefenamic acid (Mefrag-SPAS) metabolites to accumulate. Mefenamic acid (Mefrag-SPAS) (Mefenamic acid (Mefrag-SPAS)) should not be administered to patients with preexisting renal disease or in patients with significantly impaired renal function.
Clinical Studies
In controlled, double-blind, clinical trials, Mefenamic acid (Mefrag-SPAS) (Mefenamic acid (Mefrag-SPAS)) was evaluated for the treatment of primary spasmodic dysmenorrhea. The parameters used in determining efficacy included pain assessment by both patient and investigator; the need for concurrent analgesic medication; and evaluation of change in frequency and severity of symptoms characteristic of spasmodic dysmenorrhea. Patients received either Mefenamic acid (Mefrag-SPAS) (Mefenamic acid (Mefrag-SPAS)), 500 mg (2 capsules) as an initial dose of 250 mg every 6 hours, or placebo at onset of bleeding or of pain, whichever began first. After three menstrual cycles, patients were crossed over to the alternate treatment for an additional three cycles. Mefenamic acid (Mefrag-SPAS) (Mefenamic acid (Mefrag-SPAS)) was significantly superior to placebo in all parameters, and both treatments (drug and placebo) were equally tolerated.
REFERENCES
1. Neuvonen PJ, Kivisto KT: Enhancement of drug absorption by antacids. An unrecognized drug interaction. Clin Pharmacokinet. 27:120-8, Aug 1994.
2. Tall AR, Mistilits SP: Studies on Ponstan (Mefenamic acid (Mefrag-SPAS)): I. Gastro-intestinal blood loss; II. Absorption and excretion of a new formulation. J Int Med Res (UK). 1975, 3 (3) p176-82.
3. Winder CV, Kaump DH, Glazko et al: Experimental observations of flufenamic, mefenamic, and meclofenamic acids. AnnPhys Med (Eng), Suppl p7-49.1967.
9. Champion GD, Graham GG: Pharmacokinetics of non-steroidal anti-inflammatory agents. Aust NZ J Med. 8 (Supp 1): 94-100, Jun 1978.
10. McGurk KA, Remmel RP, Hosagrahara VP, Tosh D, Burchell B: Reactivity of Mefenamic acid (Mefrag-SPAS) 1-o- acyl glucuronide with proteins in vitro and ex vivo. Drug Metab Dispos. Aug 1996, 24 (8) p842-9.
11. Ito K, Niida Y, Sato J et al: Pharmacokinetics of Mefenamic acid (Mefrag-SPAS) in preterm infants with patent ductus arteriosus. Acta Paediatr JPN. 36 (4): 387-91, 1994.
References
- DailyMed. "MEFENAMIC ACID: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- NCIt. "Dicyclomine: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
- NCIt. "Mefenamic Acid: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
