Meclofenamate Sodium

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Overview

What is Meclofenamate Sodium?

Meclofenamate sodium, USP is N-(2,6-dichloro-m-tolyl) anthranilic acid, sodium salt, monohydrate. It is an anti-inflammatory drug for oral administration. Meclofenamate sodium capsules, USP contain 50 mg or 100 mg meclofenamic acid as the sodium salt and the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 3, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide.

The imprinting ink contains black iron oxide, D&C yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.

The structural formula of meclofenamate sodium is:

It is a white to creamy white, odorless to almost odorless, crystalline powder with melting point 287° to 291°C, molecular weight 336.15, and it is freely soluble in water.

What does Meclofenamate Sodium look like?

What are the available doses of Meclofenamate Sodium?

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What should I talk to my health care provider before I take Meclofenamate Sodium?

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How should I use Meclofenamate Sodium?

Carefully consider the potential benefits and risks of meclofenamate sodium capsules, USP and other treatment options before deciding to use meclofenamate sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).

Meclofenamate sodium capsules are indicated:

Meclofenamate sodium capsules are also indicated for the treatment of idiopathic heavy menstrual blood loss (see and ).

As with all nonsteroidal anti-inflammatory drugs, selection of meclofenamate sodium capsules require a careful assessment of the benefit/risk ratio (see , and ).

Meclofenamate sodium capsules are not recommended in children because adequate studies to demonstrate safety and efficacy have not been carried out.

Carefully consider the potential benefits and risks of meclofenamate sodium capsules and other treatment options before deciding to use meclofenamate sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).

After observing the response to initial therapy with meclofenamate sodium capsules, the dose and frequency should be adjusted to suit an individual patient's needs.

What interacts with Meclofenamate Sodium?

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What are the warnings of Meclofenamate Sodium?

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What are the precautions of Meclofenamate Sodium?

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What are the side effects of Meclofenamate Sodium?

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What should I look out for while using Meclofenamate Sodium?

Meclofenamate sodium capsules are contraindicated in patients with known hypersensitivity to meclofenamate sodium.

Meclofenamate sodium capsules should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see and ).

Meclofenamate sodium capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).

What might happen if I take too much Meclofenamate Sodium?

The following is based on the little information available concerning overdosage with meclofenamate sodium and related compounds. After a massive overdose, CNS stimulation may be manifested by irrational behavior, marked agitation and generalized seizures. Following this phase, renal toxicity (falling urine output, rising creatinine, abnormal urinary cellular elements) may be noted with possible oliguria or anuria and azotemia. A 24 year-old male was anuric for approximately one week after ingesting an overdose of 6 to 7 grams of meclofenamate sodium. Spontaneous diuresis and recovery subsequently occurred.

Management consists of emptying the stomach by emesis or lavage and instilling an ample dose of activated charcoal into the stomach. There is some evidence that charcoal will actively absorb meclofenamate sodium, but dialysis or hemoperfusion may be less effective because of plasma protein binding. The seizures should be controlled by an appropriate anticonvulsant regimen. Attention should be directed throughout, by careful monitoring, to the preservation of vital functions and fluid-electrolyte balance. Dialysis may be required to correct serious azotemia or electrolyte imbalance.

How should I store and handle Meclofenamate Sodium?

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.Meclofenamate Sodium Capsules, USP are available containing either 50 mg or 100 mg of meclofenamic acid as the sodium salt.The 50 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a coral opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-2150-01bottles of 100 capsulesThe 100 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a white opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-3000-01bottles of 100 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Meclofenamate Sodium Capsules, USP are available containing either 50 mg or 100 mg of meclofenamic acid as the sodium salt.The 50 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a coral opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-2150-01bottles of 100 capsulesThe 100 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a white opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-3000-01bottles of 100 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Meclofenamate Sodium Capsules, USP are available containing either 50 mg or 100 mg of meclofenamic acid as the sodium salt.The 50 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a coral opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-2150-01bottles of 100 capsulesThe 100 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a white opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-3000-01bottles of 100 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Meclofenamate Sodium Capsules, USP are available containing either 50 mg or 100 mg of meclofenamic acid as the sodium salt.The 50 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a coral opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-2150-01bottles of 100 capsulesThe 100 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a white opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-3000-01bottles of 100 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Meclofenamate Sodium Capsules, USP are available containing either 50 mg or 100 mg of meclofenamic acid as the sodium salt.The 50 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a coral opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-2150-01bottles of 100 capsulesThe 100 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a white opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-3000-01bottles of 100 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Meclofenamate Sodium Capsules, USP are available containing either 50 mg or 100 mg of meclofenamic acid as the sodium salt.The 50 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a coral opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-2150-01bottles of 100 capsulesThe 100 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a white opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-3000-01bottles of 100 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Meclofenamate Sodium Capsules, USP are available containing either 50 mg or 100 mg of meclofenamic acid as the sodium salt.The 50 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a coral opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-2150-01bottles of 100 capsulesThe 100 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a white opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-3000-01bottles of 100 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Meclofenamate Sodium Capsules, USP are available containing either 50 mg or 100 mg of meclofenamic acid as the sodium salt.The 50 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a coral opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-2150-01bottles of 100 capsulesThe 100 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a white opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-3000-01bottles of 100 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Meclofenamate Sodium Capsules, USP are available containing either 50 mg or 100 mg of meclofenamic acid as the sodium salt.The 50 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a coral opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-2150-01bottles of 100 capsulesThe 100 mg capsule is a hard-shell gelatin capsule with a coral opaque cap and a white opaque body axially printed with over in black ink on both the cap and body. The capsule is filled with an off-white powder blend. They are available as follows:NDC 0378-3000-01bottles of 100 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Meclofenamate sodium is a nonsteroidal agent which has demonstrated anti-inflammatory, analgesic, and antipyretic activity in laboratory animals. The mode of action, like that of other nonsteroidal anti-inflammatory agents, is not known. Therapeutic action does not result from pituitary-adrenal stimulation. In animal studies, meclofenamate sodium was found to inhibit prostaglandin synthesis and to compete for binding at the prostaglandin receptor site. meclofenamate sodium was found to be an inhibitor of human leukocyte 5-lipoxygenase activity. These properties may be responsible for the anti-inflammatory action of meclofenamate sodium. There is no evidence that meclofenamate sodium alters the course of the underlying disease.

In several human isotope studies, meclofenamate sodium, at a dosage of 300 mg/day, produced a fecal blood loss of 1 to 2 mL per day, and 2 to 3 mL per day at 400 mg/day. Aspirin, at a dosage of 3.6 g/day, caused a fecal blood loss of 6 mL per day.

In a multiple-dose, 1-week study in normal human volunteers, meclofenamate sodium had little or no effect on collagen-induced platelet aggregation, platelet count, or bleeding time. In comparison, aspirin suppressed collagen-induced platelet aggregation and increased bleeding time. The concomitant administration of antacids (aluminum and magnesium hydroxides) does not interfere with absorption of meclofenamate sodium.

Non-Clinical Toxicology

Meclofenamate sodium capsules are contraindicated in patients with known hypersensitivity to meclofenamate sodium.

Meclofenamate sodium capsules should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see and ).

Meclofenamate sodium capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).

Meclofenamate sodium cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

The pharmacological activity of meclofenamate sodium in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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