Meftal-Spas Tablets (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)
© All Contraceptives

Meftal-Spas tablets (Generic Mefenamic Acid and
Dicyclomine Hydrochloride tablets) are used for the
treatment of irritable bowel syndrome, stomach and intestinal
cramping, abdominal pain and dysmenorrhea (menstrual
cramps).

The active pharmaceutical ingredients contained in Meftal-Spas tablets
are Mefenamic Acid and Dicyclomine Hydrochloride.
Mefenamic Acid 250 mg and the anti-spasmodic Dicyclomine
Hydrochloride 10 mg (also known as Dicycloverine). This tablet is more
well known as Meftal 250 mg.
The Meftal Spas "DS" version that is also marketed has double strengths
of the same constituent agents with Mefenamic Acid 500 mg and
Dicyclomine Hydrochloride 20 mg. This tablet is more well known as
Meftal 500 mg.
Active Ingredients

Chemical Structure - Mefenamic Acid

Chemical Structure - Dicyclomine Hydrochloride

Meftal-Spas Tablets
Meftal-Spas Tablets are manufactured by Blue Cross
Laboratories Limited, India in the strengths of 260 mg
(Mefenamic Acid 250 mg and Dicyclomine Hydrochloride
10 mg) and 520 mg (Mefenamic Acid 500 mg and
Dicyclomine Hydrochloride 20 mg).
( Website: https://bluecrosslabs.com/ )
URL: https://www.allcontraceptives.com/meftal-spas-tablet.html

Uses of Meftal-Spas Tablets
Meftal-Spas is an effective anti-inflammatory, analgesic and
antispasmodic combination of Mefenamic Acid and Dicyclomine
Hydrochloride. This combination effectively treats the irritable bowel
syndrome, stomach and intestinal cramping, and menstrual cramps by
relaxing the smooth muscles and reducing the prostaglandin levels.
Mefenamic Acid ia an analgesic with Non steroidal anti-Inflammatory
properties. It acts by binds the prostaglandin synthetase receptors COX-1
and COX-2, inhibiting the action of prostaglandin synthetase. It is used for
the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhea, and
mild to moderate pain, inflammation, and fever.

Dicyclomine Hydrochloride is an antispasmodic and anticholinergic
(antimuscarinic) agent. It Action is achieved via a dual mechanism: a
specific anticholinergic effect (antimuscarinic) at the acetylcholine-
receptor sites, a direct effect upon smooth muscle (musculotropic).
It is used to treat a certain type of intestinal problem called irritable bowel
syndrome. It helps to reduce the symptoms of stomach and intestinal
cramping. This medication works by slowing the natural movements of the
gut and by relaxing the muscles in the stomach and intestines.
Combination of Mefenamic Acid and Dicyclomine Hydrochloride has a
Synergistic effect.

This Combination is a highly effective and used in the treatment of
spasmodic dysmenorrhoea, intestinal colic, biliary colic, ureteric colic.
Mefenamic Acid is a medication that helps in reducing the pain in the
body.Antipyretic is a drug that helps in reducing the fever by reducing the
temperature of the body to the normal temperature. Anti-inflammatory is
a kind of medication that is mainly for reducing the inflammation by
controlling the pain. Lastly Dicyclomine Hydrochloride helps in offering
relief to the cramps of the stomach, bladder and intestine.

Recommended Dosage
The dosage of Meftal-Spas tablets (Generic Mefenamic Acid and
Dicyclomine Hydrochloride tablets) is given below:
Treatment is generally required till the time dysmenorrhea (menstrual
cramps) symptoms persist i.e., 3 to 5 days during the menses. Therapy
should not be given for longer than 7 days at a time. Meftal-Spas /
Meftal-Spas DS tablets should be taken preferably with or after food.
Alternatively the dosage should be administered as prescribed by the
physician.

Contraindications
Meftal-Spas tablets are contraindicated in patients with a hypersensitivity
to Mefenamic Acid, Dicyclomine Hydrochloride or any other component
of this medication.
This medicine is also contraindicated in the following cases:
Pre-existing asthma and aspirin-sensitive asthma.
Active ulceration/bleeding or chronic inflammation of upper or lower GI
tract.
Treatment of peri-operative pain in the setting of coronary artery bypass
graft (CABG) surgery.
Pre-existing renal disease/obstructive uropathy.

Contraindications
Meftal-Spas tablets are also contraindicated in the following cases:
Glaucoma.
Myasthenia gravis.
Last trimester of pregnancy.
Lactation.
Inflammatory bowel disease, paralytic ileus and intestinal atony.

Storage Instructions
Meftal-Spas tablets (Generic Mefenamic Acid and
Dicyclomine Hydrochloride tablets) have to be
stored at controlled room temperature i.e. from
20°C to 25°C (68°F to 77°F) with excursions
permitted between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away
from children and pets.

Warnings
Mefenamic Acid:
Cardiovascular Thrombotic Events: Clinical trials of several COX-2 selective and
nonselective NSAIDs of up to 3 years duration have shown an increased risk of
serious cardiovascular (CV) thrombotic events, myocardial infarction (MI), and
stroke, which can be fatal.
Hypertension: NSAIDs, including mefenamic acid, can lead to onset of new
hypertension or worsening of pre-existing hypertension, either of which may
contribute to the increased incidence of CV events.
Congestive Heart Failure and Edema: Fluid retention and edema have been
observed in some patients taking NSAIDs. Mefenamic acid should be used with
caution in patients with fluid retention or heart failure.

Warnings
Mefenamic Acid:
Gastrointestinal Effects: Risk of Ulceration, Bleeding, and Perforation: NSAIDs,
including mefenamic acid, can cause serious gastrointestinal (GI) adverse events
including inflammation, bleeding, ulceration, and perforation of the stomach,
small intestine, or large intestine, which can be fatal. These serious adverse events
can occur at any time, with or without warning symptoms, in patients treated
with NSAIDs.
Hepatic Effects: Borderline elevations of one or more liver tests may occur in up
to 15% of patients taking NSAIDs, including mefenamic acid. These laboratory
abnormalities may progress, may remain unchanged, or may be transient with
continuing therapy.

Warnings
Mefenamic Acid:
Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis
and other renal injuries. Renal toxicity has also been seen in patients in whom renal
prostaglandins have a compensatory role in the maintenance of renal perfusion. In these
patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin
formation and, secondarily, in renal blood flow, which may precipitate overt renal
decompensation.
Anaphylactoid Reactions: As with other NSAIDs, anaphylactoid reactions may occur in
patients without known prior exposure to mefenamic acid. Mefenamic acid should not be
given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic
patients who experience rhinitis with or without nasal polyps, or who exhibit severe,
potentially fatal bronchospasm after taking aspirin or other NSAIDs.
Skin Reactions: NSAIDs, including mefenamic acid, can cause serious cutaneous adverse
events such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal
necrolysis,which can be fatal. These serious events may occur without warning.

Warnings
Mefenamic Acid:
Hematological Effects: Anemia is sometimes seen in patients receiving NSAIDs, including
Mefenamic acid. This may be due to fluid retention, GI blood loss, or an incompletely
described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs,
including Mefenamic acid, should have their hemoglobin or hematocrit checked if they
exhibit any signs or symptoms of anemia.
Preexisting Asthma: Patients with asthma may have aspirin-sensitive asthma. The use of
aspirin in patients with aspirin-sensitive asthma has been associated with severe
bronchospasm which can be fatal.
Drug / Laboratory Test Interactions: Mefenamic acid may prolong prothrombin time.
Therefore, when the drug is administered to patients receiving oral anticoagulant drugs,
frequent monitoring of prothrombin time is necessary.

Warnings
Dicyclomine Hydrochloride:
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 and result in worsening of conditions.
Peripheral and central nervous system: heat prostration can occur with drug use
(fever and heat stroke due to decreased sweating); drug should be discontinued
and supportive measures instituted.
Psychosis in patients sensitive to anticholinergic drugs: signs and symptoms
resolve within 12 to 24 hours after discontinuation of Meftal-Spas tablets.
Myasthenia Gravis: overdose may lead to muscular weakness and paralysis.
Meftal-Spas tablets should be given to patients with myasthenia gravis only to
reduce adverse muscarinic effects of an anticholinesterase.)

Warnings
Dicyclomine Hydrochloride:
Incomplete intestinal obstruction: diarrhea may be an early symptom especially in patients
with ileostomy or colostomy. Treatment with Meftal-Spas tablets would be inappropriate and
possibly fatal.
Salmonella dysenteric patients: Toxic dilatation of intestine and intestinal perforation is
possible when anticholinergic agents are administered in patients with Salmonella dysentery.
Ulcerative colitis: Meftal-Spas tablets should be used with caution in these patients; large
doses may suppress intestinal motility or aggravate the serious complications of toxic
megacolon.
Prostatic hypertrophy: Meftal-Spas tablets should be used with caution in these patients; may
lead to urinary retention.
Hepatic and renal disease: should be used with caution.
Geriatric: use with caution in elderly who may be more susceptible to Meftal-Spas tablets
adverse events.

Side Effects
The most serious side effects due to Mefenamic Acid involve the
gastrointestinal tract. Diarrhoea occasionally occurs following the use of
mefenamic acid. Although this may occur soon after starting treatment, it
may also occur after several months of continuous use.
Check with your doctor immediately if any of the following side effects occur: More
common side effects are Bloody urine, bloody, black or tarry stools, decreased frequency
or amount of urine, heartburn, increased bleeding time, increased blood pressure,
increased thirst, indigestion, itching, skin rash, loss of appetite, lower back or side
pain, nausea, pale skin, severe stomach pain, cramping, or burning, stomach
bloating, swelling of the face, fingers, feet, or lower legs, trouble breathing, unusual
bleeding or bruising, unusual tiredness or weakness, vomiting, vomiting of material
that looks like coffee grounds, severe and continuing, weight gain and weight loss.

Side Effects
The most serious side effects due to Dicyclomine Hydrochloride
include cardiovascular and central nervous system symptoms. The
most common side effects (in more than 5% of patients) are
dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia
and nervousness.

Overdose - Mefenamic Acid
Symptoms: Symptoms following acute NSAID overdose are usually limited to lethargy,
drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with
supportive care. Mefenamic acid has a tendency to induce tonic-clonic (grand mal) convulsions
in overdose. Gastrointestinal bleeding, hypertension, acute renal failure, respiratory depression
and coma may occur, but are rare. Anaphylactoid reactions have been reported with
therapeutic ingestion of NSAIDs, and may occur following an overdose.
Treatment: Patients should be managed by symptomatic and supportive care following an
NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100
g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen
within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the
usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not
be useful due to high protein binding.

Overdose - Dicyclomine Hydrochloride
Symptoms: 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: Treatment should consist of gastric lavage, emetics, and activated
charcoal. It is not known whether dicyclomine is dialyzable. 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.

Meftal-Spas Tablets During Pregnancy
Mefenamic Acid has been classified by the US FDA as Pregnancy Category C.
Dicyclomine Hydrochloride has been classified by the US FDA as Pregnancy
Category B.
For this combination product, there are no adequate and well controlled studies
available in pregnant women. Congenital abnormalities have been reported with
use of non-steroidal anti-inflammatory drugs (NSAIDs) in humans; however, these
are low in frequency and do not appear to follow any discernible pattern. In view of
the known effects of NSAIDs on the foetal cardiovascular system (risk of premature
closure of the ductus arteriosus), use of Mefenamic Acid in the last trimester of
pregnancy is contraindicated. The onset of labor may be delayed and the duration
increased with an increased bleeding tendency in both mother and child. NSAIDs,
including Mefenamic Acid, should not be used during the first two trimesters of
pregnancy or labor unless the potential benefit to the patient outweighs the possible
risk to the foetus.

For more details on
Meftal-Spas Tablets click here
Meftal-Spas (Mefenamic Acid and Dicyclomine Hydrochloride tablets)
by Blue Cross Laboratories Limited, India.

Meftal-Spas Tablets (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

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