Edym Sedante

Each tablet contains Diazepam (Edym Sedante) 2 mg, 5 mg and 10 mg, respectively. Each ampoule contain Diazepam (Edym Sedante) 10 mg/2 mL. It also contains the following excipients: Tablets: Lactose. Ampoules: Benzyl alcohol.

Each ampoule of injection contains anhydrous Metoclopramide (Edym Sedante) HCl (as Metoclopramide (Edym Sedante) HCl) 10 mg in 2 mL and sodium chloride in water for injections. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.

Metoclopramide (Edym Sedante) HCl is 4-amino-5-chloro-N-(2-diethylaminoethyl)-2-methoxybenzamide HCl monohydrate. It has a molecular weight of 354.3 and its molecular formula is C₁₄H₂₂ClN₃O₂·HCl·H₂O.

Metoclopramide (Edym Sedante) hydrochloride occurs as a white or almost white, crystalline powder or crystals, very soluble in water, freely soluble in alcohol, sparingly soluble in methylene chloride, practically insoluble in ether.

Each hard-gelatin capsule contains Pancreatin (Edym Sedante) (pancreas powder) 150 mg corresponding to amylase 8000 Ph Eur units, lipase 10,000 Ph Eur units and protease 600 Ph Eur units. It also contains the following excipients: Core Pellet: Macrogol 4000. Pellet Coating: Hypermellose phthalate, Pancreatin (Edym Sedante) 1000, triethyl citrate, cetyl alcohol. Capsule: Iron oxide (E172), titanium dioxide (E171), sodium lauryl sulphate, gelatin.

Diazepam (Edym Sedante) is a gel formulation of Diazepam (Edym Sedante) intended for rectal administration in the management of selected, refractory, patients with epilepsy, on stable regimens of AEDs, who require intermittent use of Diazepam (Edym Sedante) to control bouts of increased seizure activity.

Evidence to support the use of Diazepam (Edym Sedante) was adduced in two controlled trials that enrolled patients with partial onset or generalized convulsive seizures who were identified jointly by their caregivers and physicians as suffering intermittent and periodic episodes of markedly increased seizure activity, sometimes heralded by nonconvulsive symptoms, that for the individual patient were characteristic and were deemed by the prescriber to be of a kind for which a benzodiazepine would ordinarily be administered acutely. Although these clusters or bouts of seizures differed among patients, for any individual patient the clusters of seizure activity were not only stereotypic but were judged by those conducting and participating in these studies to be distinguishable from other seizures suffered by that patient. The conclusion that a patient experienced such unique episodes of seizure activity was based on historical information.

Dimethicone (Edym Sedante) is indicated for management and relief of irritation experienced with various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.

The use of Metoclopramide (Edym Sedante)™ (Metoclopramide (Edym Sedante) orally disintegrating tablets) is recommended for adults only. Therapy should not exceed 12 weeks in duration.

Symptomatic Gastroesophageal Reflux

Metoclopramide (Edym Sedante)™ (Metoclopramide (Edym Sedante) orally disintegrating tablets) is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy.

The principal effect of Metoclopramide (Edym Sedante) is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of Metoclopramide (Edym Sedante) as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg four times daily. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically.

Diabetic Gastroparesis (Diabetic Gastric Stasis)

Metoclopramide (Edym Sedante)™ (Metoclopramide (Edym Sedante) orally disintegrating tablets) is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to Metoclopramide (Edym Sedante) within different time intervals.

Important Limitations

Metoclopramide (Edym Sedante)™ (Metoclopramide (Edym Sedante) orally disintegrating tablets) is indicated for adults only. Therapy should not exceed 12 weeks in duration. The safety and effectiveness in pediatric patients have not been established.

Pancreatic insufficiency

Pancreatic enzyme supplements commonly cause gastrointestinal adverse effects such as abdominal discomfort and nausea and vomiting. They may also cause buccal and perianal irritation, particularly in infants. Colonic strictures (fibrosing colonopathy) have occurred, mainly in children with cystic fibrosis receiving high doses of Pancreatin (Edym Sedante) preparations; the use of high doses in patients with cystic fibrosis should preferably be avoided. Adequate hydration should be maintained at all times in patients receiving higher strength preparations.

Diazepam (Edym Sedante) is a benzodiazepine (ben-zoe-dye-AZE-eh-peen). Diazepam (Edym Sedante) affects chemicals in the brain that may be unbalanced in people with certain conditions.

Diazepam (Edym Sedante) injection is used to treat anxiety disorders, alcohol withdrawal symptoms, or muscle spasms. Diazepam (Edym Sedante) injection is also used to treat a seizure emergency called status epilepticus.

Diazepam (Edym Sedante) injection is sometimes used as a sedative to help you relax before having surgery or other medical procedure.

Diazepam (Edym Sedante) may also be used for purposes not listed in this medication guide.

Temporarily protecting and relieving minor skin irritations (eg, diaper rash). It also helps to seal out wetness. It may also be used for other conditions as determined by the patient's doctor.

This product is a skin protectant. It works by relieving skin irritation and reducing redness.

Metoclopramide (Edym Sedante) is used to treat the symptoms of a certain type of stomach problem called gastroparesis in patients with diabetes. It works by increasing the movements or contractions of the stomach and intestines. It relieves symptoms such as nausea, vomiting, heartburn, a feeling of fullness after meals, and loss of appetite. Metoclopramide (Edym Sedante) is also used to treat heartburn for patients with gastroesophageal reflux disease (GERD). GERD is esophageal irritation from the backward flow of gastric acid into the esophagus.

Metoclopramide (Edym Sedante) is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Metoclopramide (Edym Sedante) is used in certain patients with the following medical conditions:

• Failure of the stomach to empty its contents.
• Nausea and vomiting caused by other medicines.
• Persistent hiccups.
• Prevention of aspirating fluid into the lungs during surgery.
• Vascular headaches.

Pancreatin (Edym Sedante) (pancrelipase) is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Pancreatin (Edym Sedante) is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Pancreatin (Edym Sedante) may also be used following surgical removal of the pancreas.

Pancreatin (Edym Sedante) may also be used for purposes not listed in this medication guide.

This section is intended primarily for the prescriber; however, the prescriber should also be aware of the dosing information and directions for use provided in the patient package insert.

A decision to prescribe Diazepam (Edym Sedante) involves more than the diagnosis and the selection of the correct dose for the patient.

First, the prescriber must be convinced from historical reports and/or personal observations that the patient exhibits the characteristic identifiable seizure cluster that can be distinguished from the patient's usual seizure activity by the caregiver who will be responsible for administering Diazepam (Edym Sedante).

Second, because Diazepam (Edym Sedante) is only intended for adjunctive use, the prescriber must ensure that the patient is receiving an optimal regimen of standard anti-epileptic drug treatment and is, nevertheless, continuing to experience these characteristic episodes.

Third, because a non-health professional will be obliged to identify episodes suitable for treatment, make the decision to administer treatment upon that identification, administer the drug, monitor the patient, and assess the adequacy of the response to treatment, a major component of the prescribing process involves the necessary instruction of this individual.

Fourth, the prescriber and caregiver must have a common understanding of what is and is not an episode of seizures that is appropriate for treatment, the timing of administration in relation to the onset of the episode, the mechanics of administering the drug, how and what to observe following administration, and what would constitute an outcome requiring immediate and direct medical attention.

Calculating Prescribed Dose

The Diazepam (Edym Sedante) dose should be individualized for maximum beneficial effect. The recommended dose of Diazepam (Edym Sedante) is 0.2-0.5 mg/kg depending on age. See the dosing table for specific recommendations.

How supplied

Diazepam (Edym Sedante) rectal delivery system is a non-sterile, prefilled, unit dose, rectal delivery system. The rectal delivery system includes a plastic applicator with a flexible, molded tip available in two lengths, designated for convenience as 10 mg delivery system and 20 mg delivery system. The available doses from 20 mg delivery system are 12.5 mg, 15 mg, 17.5 mg, and 20 mg. The available doses from 10 mg delivery system are 5 mg, 7.5 mg and 10 mg. The Diazepam (Edym Sedante) delivery system is available in the following three presentations:

Each twin pack contains two Diazepam (Edym Sedante) delivery systems, two packets of lubricating jelly, and administration and disposal Instructions available on the bottom of the package. Diazepam (Edym Sedante) is also packed with Instructions for Caregivers upon receipt from pharmacy.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Diazepam (Edym Sedante) 10 mg delivery system and 20 mg delivery system

Distributed by: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. Manufactured By: DPT Laboratories, LTD., San Antonio, TX 78215, 9435000. Revised: Feb 2015

Directions For Use

Apply to affected area three times a day unless otherwise directed by a prescribing healthcare practitioner. Dimethicone (Edym Sedante) should be rubbed gently into the skin until it is completely absorbed.

Follow these important directions to ensure proper foaming and maximum delivery of product:

• Shake canister vigorously before each use.
• Turn upside down (nozzle down) to dispense.
• Depress ridged portion of dispenser, as illustrated at right.

How supplied

Dimethicone (Edym Sedante) is supplied in a 200 gram aerosolized canister bearing the NDC Number 23710-000-02, a 70 gram aerosolized canister bearing the NDC Number 23710-000-70, and a 10 gram aerosolized canister bearing the NDC Number 23710-000-01.

Store at controlled room temperature 15° to 25°C (59° to 77°F).

Contains flammable materials. Contents under pressure. Do not puncture and/or incinerate the containers. Do not expose to temperatures over 120°F (48°C) even when empty

Manufactured for : Quinnova Pharmaceuticals LLC., Jamison, PA 18929 (877) 660-6263. Revised: Jan 2013

Therapy with Metoclopramide (Edym Sedante)™ (Metoclopramide (Edym Sedante) orally disintegrating tablets) should not exceed 12 weeks in duration.

Instructions for Use/Handling Metoclopramide (Edym Sedante)™ (Metoclopramide (Edym Sedante) orally disintegrating tablets)

Just prior to administration, remove the Metoclopramide (Edym Sedante)™ (Metoclopramide (Edym Sedante) orally disintegrating tablets) orally disintegrating tablet from the packaging with dry hands. The tablet should be removed from the package and immediately placed on the tongue, to disintegrate and be swallowed with the saliva. The tablet typically disintegrates in about one and one-half minutes. Administration with liquid is not necessary.

Symptomatic Gastroesophageal Reflux Disease

For the relief of symptomatic, documented gastroesophageal reflux disease (GERD), therapy should not exceed 12 weeks.

Administer from 10 mg to 15 mg of Metoclopramide (Edym Sedante)™ (Metoclopramide (Edym Sedante) orally disintegrating tablets) orally up to four times daily, 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response. If symptoms occur only intermittently or at specific times of the day, use of Metoclopramide (Edym Sedante) in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of Metoclopramide (Edym Sedante) will require only 5 mg per dose.

Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using four times daily therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated. Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.

Prolonged treatment ( > 12 weeks) with Metoclopramide (Edym Sedante) should be avoided in all but rare cases where therapeutic benefit is thought to counterbalance the risks to the patient of developing tardive dyskinesia..

Diabetic Gastroparesis (Diabetic Gastric Stasis)

For the relief of symptoms associated with diabetic gastroparesis (diabetic gastric stasis), therapy of two to eight weeks is recommended. Therapy should not exceed 12 weeks in duration.

Administer 10 mg of Metoclopramide (Edym Sedante)™ (Metoclopramide (Edym Sedante) orally disintegrating tablets) 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of Metoclopramide (Edym Sedante)™ (Metoclopramide (Edym Sedante) orally disintegrating tablets) may be initiated. However, if severe symptoms are present, therapy should begin with Metoclopramide (Edym Sedante) injection (consult labeling of the injection prior to initiating parenteral administration).

Administration of Metoclopramide (Edym Sedante) injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, Metoclopramide (Edym Sedante)™ (Metoclopramide (Edym Sedante) orally disintegrating tablets) therapy should be reinstituted at the earliest manifestation.

Patients with Renal Impairment

Since Metoclopramide (Edym Sedante) is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

How supplied

Dosage Forms And Strengths

Metoclopramide (Edym Sedante)™ (Metoclopramide (Edym Sedante)) orally disintegrating tablets contains either 5 mg or 10 mg of Metoclopramide (Edym Sedante) base (as monohydrochloride monohydrate). The tablets are white, round, flat-faced, and orange flavored.

Metoclopramide (Edym Sedante)™ (Metoclopramide (Edym Sedante)) orally disintegrating tablets 5 mg base (as the monohydrochloride monohydrate) are white, round, flat-faced, orange-flavored and engraved "AP" on one side and "152" on the other side. They are supplied as follows:

Bottles of 100..................NDC 68220-152-10

Metoclopramide (Edym Sedante)™ (Metoclopramide (Edym Sedante)) orally disintegrating tablets 10 mg base (as the monohydrochloride monohydrate) are white, round, flat-faced, orange-flavored and engraved "AP"on one side and "153" on the other side. They are supplied as follows:

Bottles of 100..................NDC 68220-153-10

Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). Protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP/NF.

Manufactured for: Alaven Pharmaceuticals LLC., Marietta, GA 30062. www.alavenpharm.com. For Medical Inquiries, call toll-free 1-888-317-0001. Manufactured by: CIMA® LABS INC.

Pancreatin (Edym Sedante) is not interchangeable with other pancrelipase products.

Pancreatin (Edym Sedante) is orally administered. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of Pancreatin (Edym Sedante) should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet as described in the Limitations on Dosing below.

Administration

Infants (up to 12 months)

Pancreatin (Edym Sedante) should be administered to infants immediately prior to each feeding, using a dosage of 3,000 lipase units per 120 mL of formula or prior to breast-feeding. Contents of the capsule may be administered directly to the mouth or with a small amount of applesauce. Administration should be followed by breast milk or formula. Contents of the capsule should not be mixed directly into formula or breast milk as this may diminish efficacy. Care should be taken to ensure that Pancreatin (Edym Sedante) is not crushed or chewed or retained in the mouth, to avoid irritation of the oral mucosa.

Children and Adults

Pancreatin (Edym Sedante) should be taken during meals or snacks, with sufficient fluid. Pancreatin (Edym Sedante) capsules and capsule contents should not be crushed or chewed. Capsules should be swallowed whole.

For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents added to a small amount of acidic soft food with a pH of 4.5 or less, such as applesauce, at room temperature. The Pancreatin (Edym Sedante)-soft food mixture should be swallowed immediately without crushing or chewing, and followed with water or juice to ensure complete ingestion. Care should be taken to ensure that no drug is retained in the mouth.

Dosage

Dosage recommendations for pancreatic enzyme replacement therapy were published following the Cystic Fibrosis Foundation Consensus Conferences.1, 2, 3 Pancreatin (Edym Sedante) should be administered in a manner consistent with the recommendations of the Cystic Fibrosis Foundation Consensus Conferences (also known as Conferences) provided in the following paragraphs, except for infants. Although the Conferences recommend doses of 2,000 to 4,000 lipase units in infants up to 12 months, Pancreatin (Edym Sedante) is available in a 3,000 lipase unit capsule. Therefore, the recommended dose of Pancreatin (Edym Sedante) in infants up to 12 months is 3,000 lipase units per 120 mL of formula or per breast-feeding. Patients may be dosed on a fat ingestion-based or actual body weight-based dosing scheme.

Additional recommendations for pancreatic enzyme therapy in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy are based on a clinical trial conducted in these populations.

Infants (up to 12 months)

Pancreatin (Edym Sedante) is available in the strength of 3,000 USP units of lipase thus infants may be given 3,000 lipase units (one capsule) per 120 mL of formula or per breast-feeding. Do not mix Pancreatin (Edym Sedante) capsule contents directly into formula or breast milk prior to administration.

Children Older than 12 Months and Younger than 4 Years

Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal for children less than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Children 4 Years and Older and Adults

Enzyme dosing should begin with 500 lipase units/kg of body weight per meal for those older than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Usually, half of the prescribed Pancreatin (Edym Sedante) dose for an individualized full meal should be given with each snack. The total daily dose should reflect approximately three meals plus two or three snacks per day.

Enzyme doses expressed as lipase units/kg of body weight per meal should be decreased in older patients because they weigh more but tend to ingest less fat per kilogram of body weight.

Adults with Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy

The initial starting dose and increases in the dose per meal should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.

In one clinical trial, patients received Pancreatin (Edym Sedante) at a dose of 72,000 lipase units per meal while consuming at least 100 g of fat per day. Lower starting doses recommended in the literature are consistent with the 500 lipase units/kg of body weight per meal lowest starting dose recommended for adults in the Cystic Fibrosis Foundation Consensus Conferences Guidelines. If symptoms and signs of steatorrhea persist, the dosage may be increased by the healthcare professional. Patients should be instructed not to increase the dosage on their own. There is great inter-individual variation in response to enzymes; thus, a range of doses is recommended. Changes in dosage may require an adjustment period of several days. If doses are to exceed 2,500 lipase units/kg of body weight per meal, further investigation is warranted. Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Doses greater than 6,000 lipase units/kg of body weight per meal have been associated with colonic stricture, indicative of fibrosing colonopathy, in children less than 12 years of age. Patients currently receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.

How supplied

Dosage Forms And Strengths

The active ingredient in Pancreatin (Edym Sedante) evaluated in clinical trials is lipase. Pancreatin (Edym Sedante) is dosed by lipase units.

Other active ingredients include protease and amylase. Each Pancreatin (Edym Sedante) delayed-release capsule strength contains the specified amounts of lipase, protease, and amylase as follows:

• 3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase delayed-release capsules have a white opaque cap with imprint “Pancreatin (Edym Sedante) 1203” and a white opaque body.
• 6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase delayed-release capsules have an orange opaque cap with imprint “Pancreatin (Edym Sedante) 1206” and a blue opaque body.
• 12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase delayed-release capsules have a brown opaque cap with imprint “Pancreatin (Edym Sedante) 1212” and a colorless transparent body.
• 24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase delayed-release capsules have an orange opaque cap with imprint “Pancreatin (Edym Sedante) 1224” and a colorless transparent body.
• 36,000 USP units of lipase; 114,000 USP units of protease; 180,000 USP units of amylase delayed-release capsules have a blue opaque cap with imprint “Pancreatin (Edym Sedante) 1236” and a colorless transparent body.

Pancreatin (Edym Sedante) (pancrelipase) Delayed-Release Capsules

3,000 USP units of lipase; 9,500 USP units of protease; 15,000 USP units of amylase

Each Pancreatin (Edym Sedante) capsule is available as a two piece hypromellose capsule with a white opaque cap with imprint “Pancreatin (Edym Sedante) 1203” and a white opaque body that contains tan colored, delayed-release pancrelipase supplied in bottles of:

70 capsules (NDC 0032-1203-70)

Pancreatin (Edym Sedante) (pancrelipase) Delayed-Release Capsules

6,000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase

Each Pancreatin (Edym Sedante) capsule is available as a two-piece gelatin capsule with orange opaque cap with imprint “Pancreatin (Edym Sedante) 1206” and a blue opaque body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:

100 capsules (NDC 0032-1206-01)

250 capsules (NDC 0032-1206-07)

Pancreatin (Edym Sedante) (pancrelipase) Delayed-Release Capsules

12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase

Each Pancreatin (Edym Sedante) capsule is available as a two-piece gelatin capsule with a brown opaque cap with imprint “Pancreatin (Edym Sedante) 1212” and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:

100 capsules (NDC 0032-1212-01)

250 capsules (NDC 0032-1212-07)

Pancreatin (Edym Sedante) (pancrelipase) Delayed-Release Capsules

24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase

Each Pancreatin (Edym Sedante) capsule is available as a two-piece gelatin capsule with orange opaque cap with imprint “Pancreatin (Edym Sedante) 1224” and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:

100 capsules (NDC 0032-1224-01)

250 capsules (NDC 0032-1224-07)

Pancreatin (Edym Sedante) (pancrelipase) Delayed-Release Capsules

36,000 USP units of lipase; 114,000 USP units of protease; 180,000 USP units of amylase

Each Pancreatin (Edym Sedante) capsule is available as a two-piece gelatin capsule with blue opaque cap with imprint “Pancreatin (Edym Sedante) 1236” and a colorless transparent body that contains tan-colored, delayed-release pancrelipase supplied in bottles of:

100 capsules (NDC 0032-3016-13)

250 capsules (NDC 0032-3016-28)

Storage and Handling

Pancreatin (Edym Sedante) must be stored at room temperature up to 25°C (77°F) and protected from moisture. Temperature excursions are permitted between 25°C to 40°C (77°F and 104°F) for up to 30 days. Product should be discarded if exposed to higher temperature and moisture conditions higher than 70%. After opening, keep bottle tightly closed between uses to protect from moisture.

Bottles of Pancreatin (Edym Sedante) 3,000 USP units of lipase must be stored and dispensed in the original container.

Do not crush Pancreatin (Edym Sedante) delayed-release capsules or the capsule contents.

REFERENCES

1 Borowitz DS, Grand RJ, Durie PR, et al. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. Journal of Pediatrics. 1995; 127: 681-684.

2 Borowitz DS, Baker RD, Stallings V. Consensus report on nutrition for pediatric patients with cystic fibrosis. Journal of Pediatric Gastroenterology Nutrition. 2002 Sep; 35: 246-259.

3 Stallings VA, Stark LJ, Robinson KA, et al. Evidence-based practice recommendations for nutrition-related management of children and adults with cystic fibrosis and pancreatic insufficiency: results of a systematic review. Journal of the American Dietetic Association. 2008; 108: 832-839.

4 Dominguez-Munoz JE. Pancreatic enzyme therapy for pancreatic exocrine insufficiency. Current Gastroenterology Reports. 2007; 9: 116-122.

Manufactured by: Abbott Laboratories GmbH, Hannover, Germany. Marketed by: AbbVie Inc., North Chicago, IL 60064, U.S.A. Revised: September, 2012

See also:
What is the most important information I should know about Diazepam (Edym Sedante)?

You should not use this medication if you are allergic to Diazepam (Edym Sedante) or similar medicines (Ativan, Klonopin, Restoril, Xanax, and others), or if you have myasthenia gravis, severe liver disease, narrow-angle glaucoma, a severe breathing problem, or sleep apnea.

Do not use Diazepam (Edym Sedante) if you are pregnant. It could harm the unborn baby.

Do not start or stop taking Diazepam (Edym Sedante) during pregnancy without your doctor's advice. Diazepam (Edym Sedante) may cause harm to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Tell your doctor right away if you become pregnant while taking Diazepam (Edym Sedante) for seizures.

Before you take Diazepam (Edym Sedante), tell your doctor if you have glaucoma, asthma or other breathing problems, kidney or liver disease, seizures, or a history of drug or alcohol addiction, mental illness, depression, or suicidal thoughts.

Do not drink alcohol while taking Diazepam (Edym Sedante). This medication can increase the effects of alcohol.

Never take more of this medication than your doctor has prescribed. An overdose of Diazepam (Edym Sedante) can be fatal.

Diazepam (Edym Sedante) may be habit forming. Never share Diazepam (Edym Sedante) with another person, especially someone with a history of drug abuse or addiction.

See also:
What is the most important information I should know about Dimethicone (Edym Sedante)?

Known hypersensitivity to any of the Dimethicone (Edym Sedante) ingredients.

See also:
What is the most important information I should know about Metoclopramide (Edym Sedante)?

NEVER TAKE Metoclopramide (Edym Sedante) IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS. High doses or long-term use of Metoclopramide (Edym Sedante) can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take Metoclopramide (Edym Sedante), the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women, diabetics, and older adults.

You should not take this medication if you are allergic to Metoclopramide (Edym Sedante), or if you have bleeding or blockage in your stomach or intestines, epilepsy or other seizure disorder, or an adrenal gland tumor (pheochromocytoma).

Before you take Metoclopramide (Edym Sedante), tell your doctor if you have kidney or liver disease, congestive heart failure, high blood pressure, diabetes, Parkinson's disease, or a history of depression.

Do not drink alcohol. It can increase some of the side effects of Metoclopramide (Edym Sedante).

There are many other medicines that can interact with Metoclopramide (Edym Sedante). Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Stop using Metoclopramide (Edym Sedante) and call your doctor at once if you have tremors or uncontrolled muscle movements, fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing, depressed mood, thoughts of suicide or hurting yourself, hallucinations, anxiety, agitation, seizure, or jaundice (yellowing of your skin or eyes).

See also:
What is the most important information I should know about Pancreatin (Edym Sedante)?

Hypersensitivity to Pancreatin (Edym Sedante) or to any of the excipients of Pancreatin (Edym Sedante).

Use Diazepam (Edym Sedante) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Diazepam (Edym Sedante). Talk to your pharmacist if you have questions about this information.
• A health care provider will teach your caregiver how to use Diazepam (Edym Sedante). Be sure your caregiver understands how to use Diazepam (Edym Sedante). Contact your health care provider if you or your caregiver have any questions about using Diazepam (Edym Sedante).
• To use Diazepam (Edym Sedante), place the patient on their side where they cannot fall. Get the syringe. Push up with your thumb and remove the cap from the syringe. Be sure the seal pin is removed with the cap. Lubricate the rectal tip with the lubricating jelly provided.
• Turn the patient on their side facing you. Bend the upper leg forward and separate the buttocks to expose the rectum.
• Gently insert the syringe tip into the rectum. Slowly count to 3 while gently pushing the plunger in until it stops. Slowly count to 3 before removing the syringe from the rectum. Slowly count to 3 while holding the buttocks together to prevent leakage of the medicine.
• Keep the patient on their side facing you. Continue to observe the patient as directed by the patient's doctor.
• Do not reuse the syringe or other materials. Throw away all used materials in the trash can. Keep out of the reach of children and away from pets.
• Contact the patient's doctor at once if seizures continue for 15 minutes after using Diazepam (Edym Sedante), unless the patient's doctor tells you otherwise.
• Contact the doctor at once if you are alarmed by the frequency or severity of the seizures, or the color or breathing of the patient.
• Contact the doctor at once if the seizures are different from the patient's usual seizure episodes or if the patient is having unusual or serious problems.
• Do NOT use Diazepam (Edym Sedante) more often than once every 5 days unless your doctor tells you otherwise.
• Do NOT use Diazepam (Edym Sedante) more often than 5 times per month unless your doctor tells you otherwise.
• If you miss a dose of Diazepam (Edym Sedante), contact your doctor right away.

Ask your health care provider any questions you may have about how to use Diazepam (Edym Sedante).

Use Dimethicone (Edym Sedante) cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Dimethicone (Edym Sedante) cream is for external use only. Do not get Dimethicone (Edym Sedante) cream in your eyes, nose, or mouth. If you get Dimethicone (Edym Sedante) cream in your eyes, rinse immediately with cool tap water.
• Wash your hands before and after using Dimethicone (Edym Sedante) cream unless your hands are a part of the treated area.
• Wash and completely dry the affected area. Apply only enough of Dimethicone (Edym Sedante) cream to completely cover the affected area and gently rub in until it is evenly distributed.
• Do not wrap or bandage the treated area unless directed to do so by your doctor.
• If you miss using Dimethicone (Edym Sedante) cream for 1 or more days, there is no cause for concern. If your doctor recommended that you use it, try to remember every day.

Ask your health care provider any questions you may have about how to use Dimethicone (Edym Sedante) cream.

Use Metoclopramide (Edym Sedante) orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Metoclopramide (Edym Sedante) orally disintegrating tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Metoclopramide (Edym Sedante) orally disintegrating tablets refilled.
• Take Metoclopramide (Edym Sedante) orally disintegrating tablets by mouth 30 minutes before meals and at bedtime without food or water unless directed otherwise by your doctor.
• Do not remove the tablet from the blister pack until you are ready to take Metoclopramide (Edym Sedante) orally disintegrating tablets. Make sure that your hands are dry when you open the blister pack. If the tablet breaks or crumbles while handling, discard and remove a new tablet. Place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.
• It may take several days to weeks for Metoclopramide (Edym Sedante) orally disintegrating tablets to work. Do not stop taking Metoclopramide (Edym Sedante) orally disintegrating tablets without checking with your doctor.
• If you miss a dose of Metoclopramide (Edym Sedante) orally disintegrating tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Metoclopramide (Edym Sedante) orally disintegrating tablets.

Use Pancreatin (Edym Sedante) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pancreatin (Edym Sedante) comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Pancreatin (Edym Sedante) refilled.
• Take Pancreatin (Edym Sedante) by mouth with each meal or snack as directed by your doctor.
• Swallow Pancreatin (Edym Sedante) whole with enough liquid to swallow it completely. Do not break, crush, chew, or hold Pancreatin (Edym Sedante) in your mouth before swallowing. Doing so may increase the risk of mouth irritation from Pancreatin (Edym Sedante). Follow with a glass of water or juice. Contact your doctor if you experience mouth irritation while taking Pancreatin (Edym Sedante).
• If the patient is an infant (up to 12 months old), open the capsule and sprinkle the contents into the infant's mouth or over a small amount of applesauce at room temperature. Do NOT mix Pancreatin (Edym Sedante) directly in breast milk or formula. If sprinkled onto applesauce, give the mixture to the infant right away. After giving Pancreatin (Edym Sedante), follow it with breast milk or formula. Be sure that none of the medicine is crushed, chewed, or left in the mouth.
• If the patient is an adult or child older than 12 months old who cannot swallow the capsule whole, open it and sprinkle the contents over a small amount of acidic soft food (such as applesauce) at room temperature. Mix the medicine with the food and swallow the entire mixture right away, followed by a glass of water or juice. Be sure that none of the medicine is crushed, chewed, or left in the mouth. Check with your doctor if you are unsure which foods you may mix with Pancreatin (Edym Sedante).
• If you miss a dose of Pancreatin (Edym Sedante), skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once or take a dose without a snack or a meal.

Ask your health care provider any questions you may have about how to use Pancreatin (Edym Sedante).

Diazepam (Edym Sedante) is used to treat anxiety, muscle spasms, and alcohol withdrawal. The injection form is used when prompt relief is desired or when the medication cannot be taken by mouth.

This medication is also used for the short-term treatment of serious seizures that do not stop (status epilepticus). It is not for ongoing daily use to prevent seizures.

Diazepam (Edym Sedante) is also used before a surgery or procedure to cause drowsiness, decrease anxiety, and to help the patient forget what happened during the surgery/procedure.

This medication works by calming the brain and nerves. Diazepam (Edym Sedante) belongs to a class of drugs known as benzodiazepines.

How to use Diazepam (Edym Sedante) injection

This medication is given by injection into a vein or deep into a muscle as directed by your doctor. You should be closely monitored for several hours after receiving this medication.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

The dosage is based on your medical condition, age, and response to treatment. Giving the medication too fast into a vein can cause serious side effects. If giving this medication into a vein, inject it slowly into a large vein. Do not inject this medication into an artery or into the skin.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as shaking, abdominal/muscle cramps, vomiting, sweating, anxiety, restlessness, seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used Diazepam (Edym Sedante) for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Use this medication exactly as prescribed to lessen the risk of addiction.

Dimethicone (Edym Sedante) or dimeticone is used to treat dry, itchy skin or minor skin irritations, to relieve stomach pain, bloating and indigestion, hiccups, and infection of the scalp hair by the head louse.

This medication is used to treat certain conditions of the stomach and intestines. Metoclopramide (Edym Sedante) is used as a short-term treatment (4 to 12 weeks) for persistent heartburn when the usual medicines do not work well enough. It is used mostly for heartburn that occurs after a meal or during the daytime. Treating persistent heartburn can decrease the damage done by stomach acid to the swallowing tube (esophagus) and help healing.

Metoclopramide (Edym Sedante) is also used in diabetic patients who have poor emptying of their stomachs (gastroparesis). Treating gastroparesis can decrease symptoms of nausea, vomiting, and stomach/abdominal fullness. Metoclopramide (Edym Sedante) works by blocking a natural substance (dopamine). It speeds up stomach emptying and movement of the upper intestines.

This drug is not recommended for use in children younger than 1 year due to an increased risk of serious side effects (such as muscle spasms/uncontrolled muscle movements). Ask the doctor or pharmacist for details.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to prevent nausea/vomiting from chemotherapy or radiation treatments for cancer.

How to use Metoclopramide (Edym Sedante)

Read the Medication Guide provided by your pharmacist before you start taking Metoclopramide (Edym Sedante) and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth 30 minutes before meals and at bedtime, usually 4 times daily or exactly as directed by your doctor. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

If you are using the disintegrating tablet, do not remove the tablet from the blister pack until right before your dose. Dry your hands before using this medication. Do not use the tablet if it is broken or crumbled. Immediately after removing the tablet, place it on the tongue. Allow it to dissolve completely, then swallow it with saliva. You do not need to take this product with water.

Dosage is based on your weight, medical condition, and response to treatment. If heartburn only occurs at certain times (such as after the evening meal), your doctor may direct you to take a single dose before those times instead of taking it throughout the day. This will reduce your risk of side effects.

Because of the risk of tardive dyskinesia, do not take this more often, in larger doses, or for longer than directed by your doctor. According to the manufacturer, treatment should not exceed 12 weeks.

To treat diabetic gastroparesis, this medication is usually taken for 2 to 8 weeks until your gut is working well. This condition may recur from time to time. Your doctor may direct you to start taking this medication as soon as your symptoms reappear and stop when you feel better. Ask your doctor for directions for starting and stopping this medication.

Take this medication regularly as directed to get the most benefit from it. To help you remember, take it at the same times before a meal each day.

If this medication has been used regularly for a long time or in high doses, withdrawal symptoms (such as dizziness, nervousness, headaches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

Tell your doctor if your condition persists or worsens.

This medication contains digestive enzymes, which are natural substances needed by the body to help break down and digest food. It is used when the pancreas cannot make or does not release enough digestive enzymes into the gut to digest the food. Depending on the amount of enzymes in your product, it may be used for indigestion, as a supplement, or as replacement therapy (e.g., in chronic pancreatitis, cystic fibrosis, cancer of the pancreas, after surgery on the pancreas or gut).

Some supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use.

The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

How to use Pancreatin (Edym Sedante) 4X

Take this medication by mouth with meals and snacks as directed by your doctor.

The dosage is based on your medical condition, diet, and response to treatment.

If you are using the tablet form of the medication, make sure not to keep it in the mouth because doing so can cause irritation to the gums and cheeks. Swallow the medication with water. For the chewable tablets, chew thoroughly before swallowing.

If you are using the capsule form of the medication and swallowing is difficult, the capsule may be opened and the powder mixed with food or liquid.

Be careful not to inhale any of the powder because doing so can irritate the inside of the nose or cause an asthma attack.

Use this medication regularly to get the most benefit from it.

If your doctor has recommended that you follow a special diet, it is very important to follow the diet to get the most benefit from this medication.

Do not change brands or dosage forms of this product without consulting your doctor or pharmacist. Different products may contain different amounts of the digestive enzymes.

Tell your doctor if your condition persists or worsens.

See also:
What other drugs will affect Diazepam (Edym Sedante)?

If Diazepam (Edym Sedante) is to be combined with other psychotropic agents or other CNS depressants, careful consideration should be given to the pharmacology of the agents to be employed particularly with known compounds which may potentiate the action of Diazepam (Edym Sedante), such as phenothiazines, narcotics, barbiturates, MAO inhibitors and other antidepressants.

The clearance of Diazepam (Edym Sedante) and certain other benzodiazepines can be delayed in association with cimetidine administration. The clinical significance of this is unclear.

Valproate may potentiate the CNS-depressant effects of Diazepam (Edym Sedante).

There have been no clinical studies or reports in literature to evaluate the interaction of rectally administered Diazepam (Edym Sedante) with other drugs. As with all drugs, the potential for interaction by a variety of mechanisms is a possibility.

Effect of Other Drugs on Diazepam (Edym Sedante) Metabolism: In vitro studies using human liver preparations suggest that CYP2C19 and CYP3A4 are the principal isozymes involved in the initial oxidative metabolism of Diazepam (Edym Sedante). Therefore, potential interactions may occur when Diazepam (Edym Sedante) is given concurrently with agents that affect CYP2C19 and CYP3A4 activity. Potential inhibitors of CYP2C19 (e.g., cimetidine, quinidine, and tranylcypromine) and CYP3A4 (e.g., ketoconazole, troleandomycin, and clotrimazole) could decrease the rate of Diazepam (Edym Sedante) elimination, while inducers of CYP2C19 (e.g., rifampin) and CYP3A4 (e.g., carbamazepine, phenytoin, dexamethasone and phenobarbital) could increase the rate of elimination of Diazepam (Edym Sedante).

Effect of Diazepam (Edym Sedante) on the Metabolism of Other Drugs : There are no reports as to which isozymes could be inhibited or induced by Diazepam (Edym Sedante). But, based on the fact that Diazepam (Edym Sedante) is a substrate for CYP2C19 and CYP3A4, it is possible that Diazepam (Edym Sedante) may interfere with the metabolism of drugs which are substrates for CYP2C19, (e.g. omeprazole, propranolol, and imipramine) and CYP3A4 (e.g. cyclosporine, paclitaxel, terfenadine, theophylline, and warfarin) leading to a potential drug-drug interaction.

No information provided.

See also:
What other drugs will affect Metoclopramide (Edym Sedante)?

Anticholinergic Agents: May diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Anti-Parkinson Agents (Dopamine Agonist): Metoclopramide (Edym Sedante) may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Monitor therapy

Antipsychotic Agents: Metoclopramide (Edym Sedante) may enhance the adverse/toxic effect of Antipsychotic Agents. Avoid combination

Atovaquone: Metoclopramide (Edym Sedante) may decrease the serum concentration of Atovaquone. Management: Consider alternatives to Metoclopramide (Edym Sedante) when possible; atovaquone should only be used with Metoclopramide (Edym Sedante) if no other antiemetics are available. Consider therapy modification

CycloSPORINE (Systemic): Metoclopramide (Edym Sedante) may increase the absorption of CycloSPORINE (Systemic). Monitor therapy

CYP2D6 Inhibitors (Strong): May increase the serum concentration of Metoclopramide (Edym Sedante). Management: Reduce Metoclopramide (Edym Sedante) dose to 5 mg 4 times daily (30 minutes before each meal and at bedtime) and limit the maximum daily dose to 20 mg if combined with strong CYP2D6 inhibitors. Consider therapy modification

Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Monitor therapy

Deutetrabenazine: May enhance the adverse/toxic effect of Metoclopramide (Edym Sedante). Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Monitor therapy

Droperidol: May enhance the adverse/toxic effect of Metoclopramide (Edym Sedante). Avoid combination

Fosfomycin: Gastrointestinal Agents (Prokinetic) may decrease the serum concentration of Fosfomycin. Monitor therapy

Levosulpiride: Benzamide Derivatives may enhance the adverse/toxic effect of Levosulpiride. Monitor therapy

Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Monitor therapy

MetyroSINE: May enhance the adverse/toxic effect of Metoclopramide (Edym Sedante). Management: Seek alternatives to this combination when possible. Monitor patients receiving Metoclopramide (Edym Sedante) with metyrosine for development of extrapyramidal symptoms. Consider therapy modification

Monoamine Oxidase Inhibitors: Metoclopramide (Edym Sedante) may enhance the hypertensive effect of Monoamine Oxidase Inhibitors. Avoid combination

Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Monitor therapy

Opioid Agonists: May diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Posaconazole: Metoclopramide (Edym Sedante) may decrease the serum concentration of Posaconazole. Monitor therapy

Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Monitor therapy

Promethazine: Metoclopramide (Edym Sedante) may enhance the adverse/toxic effect of Promethazine. Avoid combination

Quinagolide: Metoclopramide (Edym Sedante) may diminish the therapeutic effect of Quinagolide. Monitor therapy

Rivastigmine: May enhance the adverse/toxic effect of Metoclopramide (Edym Sedante). Specifically, the risk of extrapyramidal adverse reactions may be increased with this combination. Avoid combination

Selective Serotonin Reuptake Inhibitors: Metoclopramide (Edym Sedante) may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Management: Seek alternatives to this combination when possible. Monitor patients receiving Metoclopramide (Edym Sedante) with selective serotonin reuptake inhibitors for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification

Serotonin/Norepinephrine Reuptake Inhibitors: Metoclopramide (Edym Sedante) may enhance the adverse/toxic effect of Serotonin/Norepinephrine Reuptake Inhibitors. Management: Seek alternatives to this combination when possible. Monitor patients receiving Metoclopramide (Edym Sedante) with serotonin/norepinephrine reuptake inhibitors for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification

Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Monitor therapy

Tacrolimus (Systemic): Metoclopramide (Edym Sedante) may increase the serum concentration of Tacrolimus (Systemic). Specifically, treatment of gastroparesis may increase tacrolimus concentrations. Monitor therapy

Tetrabenazine: Metoclopramide (Edym Sedante) may enhance the adverse/toxic effect of Tetrabenazine. Avoid combination

Thiopental: Metoclopramide (Edym Sedante) may enhance the therapeutic effect of Thiopental. Management: Consider thiopental dose reduction when used concomitantly with Metoclopramide (Edym Sedante). Monitor patient response to treatment closely if using this combination. Consider therapy modification

Tricyclic Antidepressants: Metoclopramide (Edym Sedante) may enhance the adverse/toxic effect of Tricyclic Antidepressants. Management: Seek alternatives to this combination when possible. Monitor patients receiving Metoclopramide (Edym Sedante) with tricyclic antidepressants for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification

Trimetazidine: Metoclopramide (Edym Sedante) may enhance the adverse/toxic effect of Trimetazidine. Specifically, the risk of extrapyramidal symptoms may be enhanced. Avoid combination

See also:
What other drugs will affect Pancreatin (Edym Sedante)?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: acarbose, miglitol.

See also:
What are the possible side effects of Diazepam (Edym Sedante)?

Diazepam (Edym Sedante) adverse event data were collected from double-blind, placebo-controlled studies and open-label studies. The majority of adverse events were mild to moderate in severity and transient in nature.

Two patients who received Diazepam (Edym Sedante) died seven to 15 weeks following treatment; neither of these deaths was deemed related to Diazepam (Edym Sedante).

The most frequent adverse event reported to be related to Diazepam (Edym Sedante) in the two double-blind, placebo-controlled studies was somnolence (23%). Less frequent adverse events were dizziness, headache, pain, abdominal pain, nervousness, vasodilatation, diarrhea, ataxia, euphoria, incoordination, asthma, rhinitis, and rash, which occurred in approximately 2-5% of patients.

Approximately 1.4% of the 573 patients who received Diazepam (Edym Sedante) in clinical trials of epilepsy discontinued treatment because of an adverse event. The adverse event most frequently associated with discontinuation (occurring in three patients) was somnolence. Other adverse events most commonly associated with discontinuation and occurring in two patients were hypoventilation and rash. Adverse events occurring in one patient were asthenia, hyperkinesia, incoordination, vasodilatation and urticaria. These events were judged to be related to Diazepam (Edym Sedante).

In the two domestic double-blind, placebo-controlled, parallel-group studies, the proportion of patients who discontinued treatment because of adverse events was 2% for the group treated with Diazepam (Edym Sedante), versus 2% for the placebo group. In the Diazepam (Edym Sedante) group, the adverse events considered the primary reason for discontinuation were different in the two patients who discontinued treatment; one discontinued due to rash and one discontinued due to lethargy. The primary reason for discontinuation in the patients treated with placebo was lack of effect.

Adverse Event Incidence In Controlled Clinical Trials

Table 1 lists treatment-emergent signs and symptoms that occurred in > 1% of patients enrolled in parallel-group, placebo-controlled trials and were numerically more common in the Diazepam (Edym Sedante) group. Adverse events were usually mild or moderate in intensity.

The prescriber should be aware that these figures, obtained when Diazepam (Edym Sedante) was added to concurrent antiepileptic drug therapy, cannot be used to predict the frequency of adverse events in the course of usual medical practice when patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescribing physician with one basis to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied.

TABLE 1: Treatment-Emergent Signs And Symptoms That Occurred In > 1% Of Patients Enrolled In Parallel-Group, Placebo-Controlled Trials And Were Numerically More Common In The Diazepam (Edym Sedante) Group

Other events reported by 1% or more of patients treated in controlled trials but equally or more frequent in the placebo group than in the Diazepam (Edym Sedante) group were abdominal pain, pain, nervousness, and rhinitis. Other events reported by fewer than 1% of patients were infection, anorexia, vomiting, anemia, lymphadenopathy, grand mal convulsion, hyperkinesia, cough increased, pruritus, sweating, mydriasis, and urinary tract infection.

The pattern of adverse events was similar for different age, race and gender groups.

Other Adverse Events Observed During All Clinical Trials

Diazepam (Edym Sedante) has been administered to 573 patients with epilepsy during all clinical trials, only some of which were placebo-controlled. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using modified COSTART dictionary terminology. These categories are used in the listing below. All of the events listed below occurred in at least 1% of the 573 individuals exposed to Diazepam (Edym Sedante).

All reported events are included except those already listed above, events unlikely to be drug-related, and those too general to be informative. Events are included without regard to determination of a causal relationship to Diazepam (Edym Sedante).

BODY AS A WHOLE: Asthenia

CARDIOVASCULAR: Hypotension, vasodilatation

NERVOUS: Agitation, confusion, convulsion, dysarthria, emotional lability, speech disorder, thinking abnormal, vertigo

RESPIRATORY: Hiccup

The following infrequent adverse events were not seen with Diazepam (Edym Sedante) but have been reported previously with Diazepam (Edym Sedante) use: depression, slurred speech, syncope, constipation, changes in libido, urinary retention, bradycardia, cardiovascular collapse, nystagmus, urticaria, neutropenia and jaundice. Paradoxical reactions such as acute hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia, rage, sleep disturbances and stimulation have been reported with Diazepam (Edym Sedante); should these occur, use of Diazepam (Edym Sedante) should be discontinued.

Drug Abuse And Dependence

Diazepam (Edym Sedante) is a Schedule IV controlled substance and can produce drug dependence. It is recommended that patients be treated with Diazepam (Edym Sedante) no more frequently than every five days and no more than five times per month.

Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving Diazepam (Edym Sedante) or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

Abrupt discontinuation of Diazepam (Edym Sedante) following chronic regular use has resulted in withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating). The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuation of benzodiazepines taken continuously at therapeutic levels for several months.

See also:
What are the possible side effects of Dimethicone (Edym Sedante)?

Flakes on scalp, Irritation around eyes, Itchy scalp, Rash, Headache, Skin irritation, Shortness of breath, Skin redness, Stomach upset, Hair loss, Diarrhoea

See also:
What are the possible side effects of Metoclopramide (Edym Sedante)?

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

A total of 86 subjects entered three studies with Metoclopramide (Edym Sedante); 12 subjects entered a pilot bioavailability study (BA); 44 subjects entered a bioequivalence (BE) study, and 30 subjects entered a food-effect study. The adverse reactions from the BE and food-effect study are summarized in Table 1. The pilot BA study data are not included because it was performed with a formulation different from the Metoclopramide (Edym Sedante) formulation.

The adverse experience profile seen with Metoclopramide (Edym Sedante) was similar to Metoclopramide (Edym Sedante) tablets. Thirty-three (33) adverse reactions were reported after receiving Metoclopramide (Edym Sedante) and 30 adverse reactions were reported after receiving Metoclopramide (Edym Sedante) tablets.

Table 1: Adverse Reactions in BE and Food-Effect Study in ≥ 2% of Subjects

The most frequently reported adverse reactions (greater than 2%) associated with Metoclopramide (Edym Sedante) were: nausea, vomiting, fatigue, somnolence and headache. The most frequently reported adverse reactions (greater than 2%) associated with Metoclopramide (Edym Sedante) tablets were: nausea, headache, fatigue, somnolence, and dizziness. The combined data from the fasted BE study and the food-effect study did not demonstrate any significant differences in the adverse event profile for Metoclopramide (Edym Sedante) compared to Metoclopramide (Edym Sedante) tablets.

Post-Marketing Experience

The following adverse reactions are from the cumulative post-marketing experience with Metoclopramide (Edym Sedante) tablets. Since the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

CNS Effects: Restlessness, drowsiness, fatigue, and lassitude occur in approximately 10% of patients receiving the most commonly prescribed dosage of 10 mg four times a day. Insomnia, headache, confusion, dizziness, or depression with suicidal ideation occurs less frequently. The incidence of drowsiness is greater at higher doses. There are isolated reports of seizures without clear-cut relationship to Metoclopramide (Edym Sedante). Rarely, hallucinations have been reported.

Extrapyramidal Syndromes (EPS): Acute dystonic reactions, the most common type of EPS associated with Metoclopramide (Edym Sedante), occur in approximately 0.2% of patients (1 in 500) treated with 30 to 40 mg of Metoclopramide (Edym Sedante) per day. Symptoms include involuntary movements of limbs, facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, opisthotonus (tetanus-like reactions), and rarely, stridor and dyspnea possibly due to laryngospasm; ordinarily these symptoms are readily reversed by diphenhydramine.

Drug-induced Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel rigidity, mask-like facies.

Tardive dyskinesia is most frequently characterized by involuntary movements of the tongue, face, mouth, or jaw, and sometimes by involuntary movements of the trunk and/or extremities; movements may be choreoathetotic in appearance. Motor restlessness (akathisia) may include inability to sit still, pacing, and foot tapping. These symptoms may disappear spontaneously or respond to a reduction in dosage.

Neuroleptic Malignant Syndrome: Rare occurrences of Neuroleptic Malignant Syndrome (NMS) have been reported.

Endocrine Disturbances: Galactorrhea, amenorrhea, gynecomastia, and impotence secondary to hyperprolactinemia. Fluid retention secondary to transient elevation of aldosterone.

Cardiovascular: Hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention, acute congestive heart failure, possible AV block.

Gastrointestinal: Nausea, bowel disturbances, primarily diarrhea.

Hepatic: Rarely, cases of hepatotoxicity characterized by such findings as jaundice and altered liver function tests, when Metoclopramide (Edym Sedante) was administered with other drugs with known hepatotoxic potential.

Renal: Urinary frequency and incontinence.

Hematologic: A few cases of neutropenia, leukopenia, or agranulocytosis, generally without clear-cut relationship to Metoclopramide (Edym Sedante). Methemoglobinemia in adults and especially with overdosage in neonates. Sulfhemoglobinemia in adults.

Allergic Reactions: A few cases of rash, urticaria, or bronchospasm, especially in patients with a history of asthma. Rarely, angioneurotic edema, including glossal or laryngeal edema.

Miscellaneous: Visual disturbances. Porphyria.

See also:
What are the possible side effects of Pancreatin (Edym Sedante)?

The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) that are described elsewhere in the label include fibrosing colonopathy, hyperuricemia and allergic reactions.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The short-term safety of Pancreatin (Edym Sedante) was assessed in clinical trials conducted in 121 patients with exocrine pancreatic insufficiency (EPI): 67 patients with EPI due to cystic fibrosis (CF) and 25 patients with EPI due to chronic pancreatitis or pancreatectomy were treated with Pancreatin (Edym Sedante).

Cystic Fibrosis

Studies 1 and 2 were randomized, double-blind, placebo-controlled, crossover studies of 49 patients, ages 7 to 43 years, with EPI due to CF. Study 1 included 32 patients ages 12 to 43 years and Study 2 included 17 patients ages 7 to 11 years. In these studies, patients were randomized to receive Pancreatin (Edym Sedante) at a dose of 4,000 lipase units/g fat ingested per day or matching placebo for 5 to 6 days of treatment, followed by crossover to the alternate treatment for an additional 5 to 6 days. The mean exposure to Pancreatin (Edym Sedante) during these studies was 5 days.

In Study 1, one patient experienced duodenitis and gastritis of moderate severity 16 days after completing treatment with Pancreatin (Edym Sedante). Transient neutropenia without clinical sequelae was observed as an abnormal laboratory finding in one patient receiving Pancreatin (Edym Sedante) and a macrolide antibiotic.

In Study 2, adverse reactions that occurred in at least 2 patients (greater than or equal to 12%) treated with Pancreatin (Edym Sedante) were vomiting and headache. Vomiting occurred in 2 patients treated with Pancreatin (Edym Sedante) and did not occur in patients treated with placebo; headache occurred in 2 patients treated with Pancreatin (Edym Sedante) and did not occur in patients treated with placebo.

The most common adverse reactions (greater than or equal to 4%) in Studies 1 and 2 were vomiting, dizziness, and cough. Table 1 enumerates adverse reactions that occurred in at least 2 patients (greater than or equal to 4%) treated with Pancreatin (Edym Sedante) at a higher rate than with placebo in Studies 1 and 2.

Table 1: Adverse Reactions Occurring in at Least 2 Patients (greater than or equal to 4%) in Cystic Fibrosis (Studies 1 and 2)

An additional open-label, single-arm study assessed the short-term safety and tolerability of Pancreatin (Edym Sedante) in 18 infants and children, ages 4 months to 6 years, with EPI due to cystic fibrosis. Patients received their usual pancreatic enzyme replacement therapy (mean dose of 7,000 lipase units/kg/day for a mean duration of 18.2 days) followed by Pancreatin (Edym Sedante) (mean dose of 7,500 lipase units/kg/day for a mean duration of 12.6 days). There were no serious adverse reactions. Adverse reactions that occurred in patients during treatment with Pancreatin (Edym Sedante) were vomiting, irritability, and decreased appetite, each occurring in 6% of patients.

Chronic Pancreatitis or Pancreatectomy

A randomized, double-blind, placebo-controlled, parallel group study was conducted in 54 adult patients, ages 32 to 75 years, with EPI due to chronic pancreatitis or pancreatectomy. Patients received single-blind placebo treatment during a 5-day run-in period followed by an intervening period of up to 16 days of investigatordirected treatment with no restrictions on pancreatic enzyme replacement therapy. Patients were then randomized to receive Pancreatin (Edym Sedante) or matching placebo for 7 days. The Pancreatin (Edym Sedante) dose was 72,000 lipase units per main meal (3 main meals) and 36,000 lipase units per snack (2 snacks). The mean exposure to Pancreatin (Edym Sedante) during this study was 6.8 days in the 25 patients that received Pancreatin (Edym Sedante).

The most common adverse reactions reported during the study were related to glycemic control and were reported more commonly during Pancreatin (Edym Sedante) treatment than during placebo treatment.

Table 2 enumerates adverse reactions that occurred in at least 1 patient (greater than or equal to 4%) treated with Pancreatin (Edym Sedante) at a higher rate than with placebo.

Table 2: Adverse Reactions in at Least 1 Patient (greater than or equal to 4%) in the Chronic Pancreatitis or Pancreatectomy Trial

Postmarketing Experience

Postmarketing data from this formulation of Pancreatin (Edym Sedante) have been available since 2009. The following adverse reactions have been identified during post approval use of this formulation of Pancreatin (Edym Sedante). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal disorders (including abdominal pain, diarrhea, flatulence, constipation and nausea), skin disorders (including pruritus, urticaria and rash), blurred vision, myalgia, muscle spasm, and asymptomatic elevations of liver enzymes have been reported with this formulation of Pancreatin (Edym Sedante).

Delayed- and immediate-release pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase) have been used for the treatment of patients with exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, such as chronic pancreatitis. The long-term safety profile of these products has been described in the medical literature. The most serious adverse reactions included fibrosing colonopathy, distal intestinal obstruction syndrome (DIOS), recurrence of pre-existing carcinoma, and severe allergic reactions including anaphylaxis, asthma, hives, and pruritus.