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Germfree
Chlorhexidine Gluconate + Cetrimide
Germfree
Chlorhexidine Gluconate + Cetrimide
Indications
Wounds
Indication detailsView
For cleansing and irrigating the skin and dirty wounds where an added surfactant effect is required.
Therapeutic classView
Chlorhexidine & Chloroxylenol preparations
PharmacologyView
Chlorhexidine: Chlorhexidine is an antiseptic and disinfectant which is effective against a wide range of vegetative Gram-positive and Gram-negative organisms, some viruses and some fungi. It is ineffective against bacterial spores at room temperature, and acid-fast bacteria are inhibited but not killed. It is more active against Gram-positive than Gram-negative bacteria and some species of Pseudomonas and Proteus are relatively less susceptible. Chlorhexidine is most active at a neutral or slightly acid pH and its activity may be reduced by blood and other organic matter.
Cetrimide: Cetrimide is a quaternary ammonium disinfectant with properties typical of cationic surfactants. Solutions of these surfactants have emulsifying and detergent properties and bactericidal activity against both Gram-positive and Gram-negative organisms but higher concentrations are necessary to kill the latter. The combined detergent and antibacterial properties of cetrimide make it useful in cleansing dirty or infected wounds. It is however, relatively ineffective against bacterial spores, acid-fast bacteria, viruses and fungi.
Cetrimide: Cetrimide is a quaternary ammonium disinfectant with properties typical of cationic surfactants. Solutions of these surfactants have emulsifying and detergent properties and bactericidal activity against both Gram-positive and Gram-negative organisms but higher concentrations are necessary to kill the latter. The combined detergent and antibacterial properties of cetrimide make it useful in cleansing dirty or infected wounds. It is however, relatively ineffective against bacterial spores, acid-fast bacteria, viruses and fungi.
DosageView
Rinse the area to be cleaned with water, apply the minimum amount of irrigation necessary to cover the wound area and wash gently. Rinse again thoroughly. Apply to wound as necessary. Discard remaining solution after use.
Paediatric Use: Use with care in neonates, particularly in premature infants. Chlorhexidine may cause irritation or chemical burns.
Paediatric Use: Use with care in neonates, particularly in premature infants. Chlorhexidine may cause irritation or chemical burns.
Side effectsView
Irritative skin reactions and hypersensitivity reactions to chlorhexidine have been reported. In the event that these reactions occur, discontinue use. Cetrimide may have a prolonging effect on the wound healing process.
ContraindicationsView
Known hypersensitivity to either chlorhexidine or cetrimide. Do not use to irrigate the brain, meninges, eyes or perforated eardrum.
PrecautionsView
For external use only. Not for injection, for irrigation only. Not isotonic and is haemolytic. Cetrimide may have a prolonging effect on the wound healing process. Use of this antiseptic should be restricted to infection control and cleansing of wounds rather than general wound management.
Pregnancy & lactationView
Pregnancy: There are no adequate data from the use of chlorhexidine and cetrimide in pregnant women. The potential risk for humans is unknown but is most likely very low since chlorhexidine and cetrimide are poorly absorbed following topical application.
Breastfeeding: It is not known whether chlorhexidine and cetrimide are excreted in breast milk. There are no adequate data from the use of chlorhexidine and cetrimide in breast-feeding women. However, it is unlikely that the products are excreted in breast milk, since the products are poorly absorbed. After topical usage of the product, as a general precaution, rinse nipples thoroughly with water before breastfeeding.
Breastfeeding: It is not known whether chlorhexidine and cetrimide are excreted in breast milk. There are no adequate data from the use of chlorhexidine and cetrimide in breast-feeding women. However, it is unlikely that the products are excreted in breast milk, since the products are poorly absorbed. After topical usage of the product, as a general precaution, rinse nipples thoroughly with water before breastfeeding.
Overdose effectsView
While accidental ingestion is unlikely to cause any systemic effects due to poor absorption of chlorhexidine and cetrimide, ingestion of high concentrations could cause irritation of the gastrointestinal mucosa/gastritis. Gastric lavage might be needed. Symptomatic treatment should be employed. If swallowed, wash out mouth, drink plenty of milk or water and seek medical advice. In case of overdose, seek medical attention or contact a poison control centre.
StorageView
Store below 25°C. Protect from light. Single use only. Discard unused portion.
Germfree
Chlorhexidine Gluconate + Cetrimide
Germfree
Chlorhexidine Gluconate + Cetrimide
Indications
Wounds
Indication detailsView
For cleansing and irrigating the skin and dirty wounds where an added surfactant effect is required.
Therapeutic classView
Chlorhexidine & Chloroxylenol preparations
PharmacologyView
Chlorhexidine: Chlorhexidine is an antiseptic and disinfectant which is effective against a wide range of vegetative Gram-positive and Gram-negative organisms, some viruses and some fungi. It is ineffective against bacterial spores at room temperature, and acid-fast bacteria are inhibited but not killed. It is more active against Gram-positive than Gram-negative bacteria and some species of Pseudomonas and Proteus are relatively less susceptible. Chlorhexidine is most active at a neutral or slightly acid pH and its activity may be reduced by blood and other organic matter.
Cetrimide: Cetrimide is a quaternary ammonium disinfectant with properties typical of cationic surfactants. Solutions of these surfactants have emulsifying and detergent properties and bactericidal activity against both Gram-positive and Gram-negative organisms but higher concentrations are necessary to kill the latter. The combined detergent and antibacterial properties of cetrimide make it useful in cleansing dirty or infected wounds. It is however, relatively ineffective against bacterial spores, acid-fast bacteria, viruses and fungi.
Cetrimide: Cetrimide is a quaternary ammonium disinfectant with properties typical of cationic surfactants. Solutions of these surfactants have emulsifying and detergent properties and bactericidal activity against both Gram-positive and Gram-negative organisms but higher concentrations are necessary to kill the latter. The combined detergent and antibacterial properties of cetrimide make it useful in cleansing dirty or infected wounds. It is however, relatively ineffective against bacterial spores, acid-fast bacteria, viruses and fungi.
DosageView
Rinse the area to be cleaned with water, apply the minimum amount of irrigation necessary to cover the wound area and wash gently. Rinse again thoroughly. Apply to wound as necessary. Discard remaining solution after use.
Paediatric Use: Use with care in neonates, particularly in premature infants. Chlorhexidine may cause irritation or chemical burns.
Paediatric Use: Use with care in neonates, particularly in premature infants. Chlorhexidine may cause irritation or chemical burns.
Side effectsView
Irritative skin reactions and hypersensitivity reactions to chlorhexidine have been reported. In the event that these reactions occur, discontinue use. Cetrimide may have a prolonging effect on the wound healing process.
ContraindicationsView
Known hypersensitivity to either chlorhexidine or cetrimide. Do not use to irrigate the brain, meninges, eyes or perforated eardrum.
PrecautionsView
For external use only. Not for injection, for irrigation only. Not isotonic and is haemolytic. Cetrimide may have a prolonging effect on the wound healing process. Use of this antiseptic should be restricted to infection control and cleansing of wounds rather than general wound management.
Pregnancy & lactationView
Pregnancy: There are no adequate data from the use of chlorhexidine and cetrimide in pregnant women. The potential risk for humans is unknown but is most likely very low since chlorhexidine and cetrimide are poorly absorbed following topical application.
Breastfeeding: It is not known whether chlorhexidine and cetrimide are excreted in breast milk. There are no adequate data from the use of chlorhexidine and cetrimide in breast-feeding women. However, it is unlikely that the products are excreted in breast milk, since the products are poorly absorbed. After topical usage of the product, as a general precaution, rinse nipples thoroughly with water before breastfeeding.
Breastfeeding: It is not known whether chlorhexidine and cetrimide are excreted in breast milk. There are no adequate data from the use of chlorhexidine and cetrimide in breast-feeding women. However, it is unlikely that the products are excreted in breast milk, since the products are poorly absorbed. After topical usage of the product, as a general precaution, rinse nipples thoroughly with water before breastfeeding.
Overdose effectsView
While accidental ingestion is unlikely to cause any systemic effects due to poor absorption of chlorhexidine and cetrimide, ingestion of high concentrations could cause irritation of the gastrointestinal mucosa/gastritis. Gastric lavage might be needed. Symptomatic treatment should be employed. If swallowed, wash out mouth, drink plenty of milk or water and seek medical advice. In case of overdose, seek medical attention or contact a poison control centre.
StorageView
Store below 25°C. Protect from light. Single use only. Discard unused portion.
Germgurd
Ethanol + Isopropyl alcohol
Germgurd
Ethanol + Isopropyl alcohol
Indications
Topical antiseptic
Indication detailsView
They are liquids used primarily as a topical antiseptic. They also have multiple industrial and household uses. The term "rubbing alcohol" has become a general non-specific term for either isopropyl alcohol (isopropanol) or ethyl alcohol (ethanol) rubbing-alcohol products.
Therapeutic classView
Bleaching and Disinfectants
PharmacologyView
Ethanol and isopropyl alcohol are both members of the alcohol family and have similar disinfectant properties. Ethanol is the type of alcohol present in alcoholic beverages. Isopropyl alcohol is also known as isopropanol, 2-propanol or rubbing alcohol. When used as disinfectants, both are typically at a concentration of 70 percent in water.
DosageView
- শুকেনা হােতর তালুেত ১-২ বার ক্লিন জেল প্রয়োগ করুন।
- দুই হােতর তালু একসােথ ভােলাভােব ঘষুন।
- আঙুেলর মােঝ ও নেখর ভেতরেও প্রয়োগ করুন এবং না শুকােনা পর্যন্ত ঘষুন।
- কেয়ক সেকেন্ডর মধ্যেই হাত শুিকিয় জীবাণু মুক্ত হয়ে যাবে
PrecautionsView
শিশুদের নাগােলর বাইের রাখুন ।
StorageView
আলো ও তাপ থেকে দূরে, ঘরের স্বাভাবিক তপমাত্রায় রাখুন
Germgurd
Isopropyl Alcohol + Hydrogen Peroxide + Glycerol
Germgurd
Isopropyl Alcohol + Hydrogen Peroxide + Glycerol
Indications
Preoperative hand disinfection
Indication detailsView
This hand sanitizer is generally used to decrease infectious agents on the hands and is the most commonly used disinfectant in pharmaceutical industries. The important thing is that only 70% solution of isopropyl alcohol acts as a disinfectant killing all surface microorganisms. It is used to disinfect hands and equipment surface in pharmaceuticals.
Therapeutic classView
Bleaching and Disinfectants
PharmacologyView
Isopropyl Alcohol is an isomer of propyl alcohol with antibacterial properties. Although the exact mechanism of isopropanol's disinfecting action is not known, it might kill cells by denaturing cell proteins and DNA, interfering with cellular metabolism, and dissolving cell lipo-protein membranes. Isopropanol is used in soaps and lotions as an antiseptic. 70 % isopropyl alcohol solution kills microorganisms by dissolving plasma membrane of the cell wall.
Glycerol: used as humectant, but other emollients may be used for skin care, provided that they are cheap, widely available and miscible in water and alcohol and do not add to toxicity, or promote allergy.
Hydrogen peroxide: used to inactivate contaminating bacterial spores in the solution and is not an active substance for hand antisepsis.
Glycerol: used as humectant, but other emollients may be used for skin care, provided that they are cheap, widely available and miscible in water and alcohol and do not add to toxicity, or promote allergy.
Hydrogen peroxide: used to inactivate contaminating bacterial spores in the solution and is not an active substance for hand antisepsis.
DosageView
Alcohol-based hand sanitizer is more convenient compared to hand washing with soap and water in most situations in the healthcare setting. It is generally more effective at killing microorganisms and better tolerated than soap and water. Alcohol-based hand sanitizer is recommended only if soap and water are not available. Using guideline is given bellow-
- Apply product to the palm of one hand.
- Rub hands together.
- Rub the product over all surfaces of hands and fingers until hands are dry.
Side effectsView
Inhaling large amounts of isopropyl alcohol can cause nausea, vomiting, irritation of the nose and mucous membranes, throat irritations, and even difficulty with breathing as coughing can occur making it difficult for you to catch your breath. Isopropyl alcohol may cause burning, stinging, or a cold feeling where the medicine is applied.
ContraindicationsView
Isopropyl Alcohol is contraindicated in patients with known Hypersensitivity.
PrecautionsView
Isopropyl Alcohol is highly flammable in the presence of heat, sparks, or an open flame. When handling isopropyl alcohol in a work environment (to best to avoid any contact with skin) protective clothing should be always be worn, including safety gloves and goggles. Isopropyl alcohol should be kept away from heat, sparks, flames and other sources of ignition, as well as strong oxidizers, acetaldehyde, chlorine, ethylene oxide, acids, and isocyanates. A flammable safety cabinet is the best storage option.
StorageView
Isopropyl alcohol should be stored in a tightly closed container in a cool & dry place, protected from light, well-ventilated area. Due to the chemical's extreme flammability, it must be kept away from all possible ignition sources, including heat, sparks, and flames. Keep out of reach of children.
Germicord
Chlorhexidine Gluconate [7.1%]
Germicord
Chlorhexidine Gluconate [7.1%]
Indications
Prophylaxis of omphalitis
Indication detailsView
Chlorhexidine Gluconate 7.1% Solution is indicated for prophylaxis of omphalitis (infection of the umbilical cord) in newborn.
Therapeutic classView
Bleaching and Disinfectants
PharmacologyView
Chlorhexidine is a broad-spectrum biocide effective against Gram-positive bacteria, Gramnegative bacteria and fungi. It has both bacteriostatic and bactericidal action, depending on its concentration. Chlorhexidine kills by disrupting the cell membrane. Upon application in vitro, Chlorhexidine can kill nearly 100% of Gram-positive and Gram-negative bacteria within 30 seconds. Since Chlorhexidine formulations can destroy the majority of categories of microbes, there is limited risk for the development of opportunistic infections.
Chlorhexidine is cationic in nature and binds strongly to skin. Data relating to topical administration in neonates are limited. There are no data on metabolism of Chlorhexidine following topical administration.
Chlorhexidine is cationic in nature and binds strongly to skin. Data relating to topical administration in neonates are limited. There are no data on metabolism of Chlorhexidine following topical administration.
DosageView
Immediately after cutting the cord, 7.1% Chlorhexidine Gluconate should be applied to the tip of the cord, the stump and around the base of the stump.
AdministrationView
Chlorhexidine ব্যবহারের পূর্বে ও পরে হাত ভালো করে সাবান ও পানি দিয়ে ধুয়ে ফেলুন। Chlorhexidine এর ড্রপার বোতল চেপে সলিউশনটি নবজাতকের জন্মের পরপর কাটা নাড়ীর অগ্রভাগ, চারপাশ ও গোড়ায় এমনভাবে লাগান যেন সম্পূর্ণ নাড়ীটি ভালো ভাবে ভিজে যায়। Chlorhexidine লাগানোর পর নাড়ী কোন কিছু দিয়ে মুছবেন না। একবার Chlorhexidine লাগানোর পর নাড়ী শুষ্ক রাখুন ও নাড়ীতে অন্য কোন কিছুই লাগাবেন না। চোখে লাগাবেন না।
PrecautionsView
For external use only. Do not inject or swallow. Keep out of the eyes and ears and do not use over large areas of the body. If the product comes into contact with the eyes, wash out promptly and thoroughly with clean water. There have been reports of hypersensitivity and skin irritation after topical administration of Chlorhexidine, including generalized allergic reactions and anaphylactic shock. The prevalence of Chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. The application of this product should be discontinued and immediate medical help should be sought in case of any symptoms which may indicate an allergic reaction. If skin irritation or redness occurs, prompt medical advice should be sought.
Pregnancy & lactationView
Not applicable for the intended patient population.
StorageView
শিশুদের নাগালের বাইরে রাখুন। আলো থেকে দূরে, ঠাণ্ডা (৩০° সে. এর নিচে) ও শুষ্ক স্থানে রাখুন। কেবলমাত্র রেজিস্টার্ড চিকিৎসকের ব্যবস্থাপত্র অনুযায়ী ব্যবহার্য ও বিক্রয়যোগ্য।
Germisol
Chlorhexidine Gluconate + Isopropyl alcohol
Germisol
Chlorhexidine Gluconate + Isopropyl alcohol
Indications
Preoperative hand disinfection
Indication detailsView
For the disinfection of clean and intact skin. For pre-operative surgical hand disinfection, hand disinfection on the ward prior to aseptic procedures or after handling contaminated materials. For disinfection of the patients’ skin prior to surgery or other invasive procedures
Therapeutic classView
Chlorhexidine & Chloroxylenol preparations
PharmacologyView
Chlorhexidine is a very potent cationic chemoprophylactic agent that has a broad-spectrum of activity against gm+ve and gm-ve bacteria. It is both bacteriostatic and bactericidal depending on its concentration. The bactericidal effect, which is achieved at high concentrations, is due to the binding of the cationic to negatively charged bacterial cell walls and extramicrobial complexes. Bacteriostatic effect is achieved at low concentrations which causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorus.
DosageView
Pre-operative surgical hand disinfection: Dispense 5 ml of solution and spread thoroughly over both hands and forearms, rubbing vigorously. When dry apply a further 5 ml and repeat the procedure.
Antiseptic hand disinfection on the ward: Dispense 3 ml of solution and spread thoroughly over the hands and wrists rubbing vigorously until dry.
Disinfection of patients skin: Prior to surgery apply the solution to a sterile swab and rub vigorously over the operation site for a minimum of 2 minutes. Chlorhexidine Gluconate is also used for preparation of the skin prior to invasive procedures such as venepuncture.
Antiseptic hand disinfection on the ward: Dispense 3 ml of solution and spread thoroughly over the hands and wrists rubbing vigorously until dry.
Disinfection of patients skin: Prior to surgery apply the solution to a sterile swab and rub vigorously over the operation site for a minimum of 2 minutes. Chlorhexidine Gluconate is also used for preparation of the skin prior to invasive procedures such as venepuncture.
Side effectsView
Irritative skin reactions can occasionally occur. Generalised allergic reactions have also been reported but are extremely rare
ContraindicationsView
Chlorhexidine Gluconate is contraindicated for persons who have previously shown a hypersensitivity reaction to chlorhexidine. However, such reactions are extremely rare.
PrecautionsView
Avoid contact with brain, meninges, middle ear or sensitive tissues and eyes. Do not inject or use in body cavities.
InteractionsView
Chlorhexidine is incompatible with soaps and other anionic agents. Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with chlorhexidine solutions.
Pregnancy & lactationView
No untoward effects are known
Overdose effectsView
Symptoms: Pharyngeal oedema, necrotic lesions of the esophagus and elevated serum aminotransferase concentrations.
Management: Gastric lavage using milk, raw egg, gelatin or mild soap, or employ appropriate supportive measures.
Management: Gastric lavage using milk, raw egg, gelatin or mild soap, or employ appropriate supportive measures.
StorageView
Do not store above 25° C.
Germlock
Ethanol + Isopropyl alcohol
Germlock
Ethanol + Isopropyl alcohol
Indications
Topical antiseptic
Indication detailsView
They are liquids used primarily as a topical antiseptic. They also have multiple industrial and household uses. The term "rubbing alcohol" has become a general non-specific term for either isopropyl alcohol (isopropanol) or ethyl alcohol (ethanol) rubbing-alcohol products.
Therapeutic classView
Bleaching and Disinfectants
PharmacologyView
Ethanol and isopropyl alcohol are both members of the alcohol family and have similar disinfectant properties. Ethanol is the type of alcohol present in alcoholic beverages. Isopropyl alcohol is also known as isopropanol, 2-propanol or rubbing alcohol. When used as disinfectants, both are typically at a concentration of 70 percent in water.
DosageView
- শুকেনা হােতর তালুেত ১-২ বার ক্লিন জেল প্রয়োগ করুন।
- দুই হােতর তালু একসােথ ভােলাভােব ঘষুন।
- আঙুেলর মােঝ ও নেখর ভেতরেও প্রয়োগ করুন এবং না শুকােনা পর্যন্ত ঘষুন।
- কেয়ক সেকেন্ডর মধ্যেই হাত শুিকিয় জীবাণু মুক্ত হয়ে যাবে
PrecautionsView
শিশুদের নাগােলর বাইের রাখুন ।
StorageView
আলো ও তাপ থেকে দূরে, ঘরের স্বাভাবিক তপমাত্রায় রাখুন
Geston
Allylestrenol
Geston
Allylestrenol
Indications
Threatened abortion
Indication detailsView
Allylestrenol is indicated in:
- Intra Uterine Growth Retardation (IUGR)
- Threatened abortion
- Habitual abortion
- Threatened premature delivery
Therapeutic classView
Female Sex hormones
PharmacologyView
Allylestrenol has been found to have a relatively weak progestational effect on the human endometrium. To obtain a full secretory endometrium in oestrogen-primed castrated women or to postpone menstruation (with an oestrogen added) in normal ovulating women, doses of allylestrenol were required which were higher than those recommended for the treatment/prevention of abortion.
In vitro studies have shown that allylestrenol stimulates the synthesis of progesterone in the human placenta. It also brought about a significant (p/. 0,01) increase in the production of some specific placental enzymes (cystine aminopeptidase and heat-stable alkaline phosphatase).
Histological and histochemical changes indicating an increased activity have been found in the placenta, particularly in the syncytiotrophoblast of women with a normal and threatened pregnancy, treated with allylestrenol. The stimulatory effect of allylestrenol on placental function was also suggested by the increased level of placental hormones (pregnanediol, oestriol, HCG and HPL) and enzymes (oxytocinase, CAP) in the maternal urine and plasma, which followed the administration of the drug e.g. in the early weeks as well as in the last trimester of pregnancy.
A study in full-term pregnant women revealed that allylestrenol in high doses (up to 100 mg daily) did suppress the intensity of spontaneous uterine contractions, but had no effect on the sensitivity of the uterine muscle to oxytocin, and no adverse effect on the progress of normal delivery.
Studies in non-pregnant women with and without endocrinological disorders have shown that allylestrenol has no oestrogenic or androgenic properties and no adverse effects on the adrenal function.
No abnormal liver function tests or water and salt retention were observed in healthy female volunteers (non pregnant) who were given allylestrenol.
In vitro studies have shown that allylestrenol stimulates the synthesis of progesterone in the human placenta. It also brought about a significant (p/. 0,01) increase in the production of some specific placental enzymes (cystine aminopeptidase and heat-stable alkaline phosphatase).
Histological and histochemical changes indicating an increased activity have been found in the placenta, particularly in the syncytiotrophoblast of women with a normal and threatened pregnancy, treated with allylestrenol. The stimulatory effect of allylestrenol on placental function was also suggested by the increased level of placental hormones (pregnanediol, oestriol, HCG and HPL) and enzymes (oxytocinase, CAP) in the maternal urine and plasma, which followed the administration of the drug e.g. in the early weeks as well as in the last trimester of pregnancy.
A study in full-term pregnant women revealed that allylestrenol in high doses (up to 100 mg daily) did suppress the intensity of spontaneous uterine contractions, but had no effect on the sensitivity of the uterine muscle to oxytocin, and no adverse effect on the progress of normal delivery.
Studies in non-pregnant women with and without endocrinological disorders have shown that allylestrenol has no oestrogenic or androgenic properties and no adverse effects on the adrenal function.
No abnormal liver function tests or water and salt retention were observed in healthy female volunteers (non pregnant) who were given allylestrenol.
DosageView
Intra Uterine Growth Retardation: 1 tablet three times a day at least two months. Dose to be reduced if symptoms improve.
Threatened abortion: 1 tablet three times daily until symptoms disappear.
Habitual abortion: 1-2 tablets daily as soon as pregnancy is diagnosed. The administration should be continued for at least one month after the end of the critical period.
Threatened premature delivery: Dosage must be determined individually. High dosages (up to 40 mg daily) have been used.
In case of a missed dose, it should be taken as soon as the patient remembers & she should continue the regular dosing schedule. A double dose is not recommended.
Threatened abortion: 1 tablet three times daily until symptoms disappear.
Habitual abortion: 1-2 tablets daily as soon as pregnancy is diagnosed. The administration should be continued for at least one month after the end of the critical period.
Threatened premature delivery: Dosage must be determined individually. High dosages (up to 40 mg daily) have been used.
In case of a missed dose, it should be taken as soon as the patient remembers & she should continue the regular dosing schedule. A double dose is not recommended.
Side effectsView
Treatment with Allylestrenol (especially a long term treatment) is known to cause some gastrointestinal complaints such as vomiting, nausea, and sometimes epigastric discomfort.
ContraindicationsView
- Breast Cancer or history of problem with the breasts like- Nodules,an abnormal Mammogram, or Fibrocystic Diseases.
- Severe liver disease such as Cholestatic Jaundice or Hepatitis, Hepatic Cell Tumours, Rotor Syndrome and Dubin Jhonson Syndrome.
- Undiagnosed vaginal bleeding
- Toxaemia of Pregnancy
- Crisis Seizures, Migraines
PrecautionsView
Patients with the following conditions should be cautious: Heart disease, congestive heart failure, sick sinus syndrome, coronary artery disease, seizures, epilepsy, renal dysfunction, migraine headaches, or breathing diseases including asthma, emphysema, chronic bronchitis, or COPD, breast-feeding.
Pregnancy & lactationView
Allylestrenol is specifically designed to be taken during pregnancy. It should be discontinued after delivery as it may affect a nursing infant to a small but noticeable degree.
Pediatric usageView
It should not be used for children younger than 16 years old.
Overdose effectsView
Symptoms of overdose may include unusual drowsiness; rapid pulse; fainting; unusual muscle movement or rigidity of the face, neck, or limbs; seizures; and loss of consciousness.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Gestop 28
Ethinyl Estradiol + Gestodene
Gestop 28
Ethinyl Estradiol + Gestodene
Indications
Oral contraceptives
Indication detailsView
This pill is indicated for the prevention of pregnancy.
Therapeutic classView
Oral Contraceptive preparations
PharmacologyView
This contains two active ingredients, Gestodene and Ethinylestradiol. Ethinylestradiol is a synthetic version of oestrogen and Gestodene is a synthetic form of progesterone. If this tablet is taken according to instructions the egg cells (normally released by the ovary each month) are prevented from maturing to the point where they can be fertilized. Secondary mechanisms, which may contribute to the effectiveness of Gestop 28 as a contraceptive, include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).
DosageView
How to Take this pill: To achieve maximum contraceptive effectiveness, Gestodene & Ehinylestradiol must be taken in the order directed on the package and at intervals not exceeding 24 hours. Women should be instructed to take the tablets at about the same time every day, preferably after the evening meal or at bedtime. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started on the day after the current pack is completed.
- If you have decided to take Gestodene & Ehinylestradiol for contraception, wait for your next menstruation begins.
- From the first day of your menstruation, start taking the first white tablet from the left corner of the top row (with arrow mark indicating begin) of your Gestodene & Ehinylestradiol tablet pack.
- Continue taking one white tablet each day along the arrow mark.
- After taking 21 white tablets for 21 days, then continue taking the light red placebo tablet every day from the last row in the pack for next 7 days.
- It is most likely that your menstruation will start while taking the light red inactive tablets. Do not discontinue taking the light red inactive tablets. Taking of the light red tablets for 7 days will help you keep your tablet taking routine. If your menstruation does not start during this time, check with your doctor to make sure you are not pregnant.
- After completing the seven light red inactive tablets, start taking white active tablets from another Gestodene & Ehinylestradiol pack and continue taking the tablet as long as you don't want to be pregnant.
Management of Missed Tablets: If you forgot to take a tablet one day, take the missed tablet as soon as you remember. This may mean taking two tablets the very next day. Additionally you should use some other method of contraception while you are taking the tablets & until your next menstruation.
If you forget to take the tablets for two continuous days, then it is likely that you will no longer be protected against pregnancy. You should therefore discontinue taking the tablet and adopt some other temporary methods (condom/foam tablet) till your next menstruation. Discard the unfinished pack of tablets and start taking tablets from the very first white tablet of the top row from a fresh pack from the first day of next menstruation.
How to Delay a Period: To delay a period you should continue with another new pack of Gestodene & Ehinylestradiol just after finishing the white active tablet of the present pack (that is no need to take light redplacebo tablet of present pack). The extension can be carried on for as long as wished until the end of the second pack. When you wish your period to begin, just stop tablet taking. While using the second pack woman may have some breakthrough bleeding or spotting. Start with your next pack after the usual 7 day light red inactive tablet interval.
Advice in Case of Vomiting: If vomiting occurs within 3-4 hours after white active tablet taking, absorption may not be complete. In such an event, the advice concerning Management of Missed Tablets is applicable. The woman must take the extra active tablet(s) needed from a back up pack after vomiting.
Side effectsView
At the initial stage some women may experience side-effects like dizziness, headache, nausea, diarrhea, abdominal pain, weight gain, fluid retension, depression, mood changes, breast pain, breast tenderness, rash, vaginal discharge, erythema etc. If taken regularly, such types of side-effects normally lessen with time. If she continues to have the side effects beyond 2-3 months, she could consult with a doctor.
PrecautionsView
Some medications may interfere with the efficacy of the tablet. Contact your doctor if you are taking any drugs, such as antibiotics, rifampicin or medicines for seizures. You may have to use another method of contraception during this time.
InteractionsView
- Interactions between ethinyloestradiol and other drugs may lead to decreased or increased ethinyloestradiol concentrations, respectively. Decreased ethinyloestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the oral contraceptive. Example of substances that may decrease serum ethinyloestradiol concentrations include rifampicin, phenytoin, primidone, rifabutin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil, ritonavir and barbiturates.
- Certain antibiotics including ampicillin, other penicillins and tetracyclines may reduce the efficacy of oral contraceptives.
- During concomitant use of Gestodene & Ehinylestradiol & other drugs that may lead to decreased ethinyloestradiol serum concentrations, it is recommended that a non hormonal back-up method of contraception to be used in addition to the regular intake of this pill.
Pregnancy & lactationView
Use during pregnancy: The administration of this pill is contraindicated during pregnancy.
Use during lactation: The use of this pill during breast-feeding is not recommended.
Use during lactation: The use of this pill during breast-feeding is not recommended.
Overdose effectsView
Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness, fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.
StorageView
Store in a cool, dry place. Keep away from light & out of reach of children.
Gestrenol
Allylestrenol
Gestrenol
Allylestrenol
Indications
Threatened abortion
Indication detailsView
Allylestrenol is indicated in:
- Intra Uterine Growth Retardation (IUGR)
- Threatened abortion
- Habitual abortion
- Threatened premature delivery
Therapeutic classView
Female Sex hormones
PharmacologyView
Allylestrenol has been found to have a relatively weak progestational effect on the human endometrium. To obtain a full secretory endometrium in oestrogen-primed castrated women or to postpone menstruation (with an oestrogen added) in normal ovulating women, doses of allylestrenol were required which were higher than those recommended for the treatment/prevention of abortion.
In vitro studies have shown that allylestrenol stimulates the synthesis of progesterone in the human placenta. It also brought about a significant (p/. 0,01) increase in the production of some specific placental enzymes (cystine aminopeptidase and heat-stable alkaline phosphatase).
Histological and histochemical changes indicating an increased activity have been found in the placenta, particularly in the syncytiotrophoblast of women with a normal and threatened pregnancy, treated with allylestrenol. The stimulatory effect of allylestrenol on placental function was also suggested by the increased level of placental hormones (pregnanediol, oestriol, HCG and HPL) and enzymes (oxytocinase, CAP) in the maternal urine and plasma, which followed the administration of the drug e.g. in the early weeks as well as in the last trimester of pregnancy.
A study in full-term pregnant women revealed that allylestrenol in high doses (up to 100 mg daily) did suppress the intensity of spontaneous uterine contractions, but had no effect on the sensitivity of the uterine muscle to oxytocin, and no adverse effect on the progress of normal delivery.
Studies in non-pregnant women with and without endocrinological disorders have shown that allylestrenol has no oestrogenic or androgenic properties and no adverse effects on the adrenal function.
No abnormal liver function tests or water and salt retention were observed in healthy female volunteers (non pregnant) who were given allylestrenol.
In vitro studies have shown that allylestrenol stimulates the synthesis of progesterone in the human placenta. It also brought about a significant (p/. 0,01) increase in the production of some specific placental enzymes (cystine aminopeptidase and heat-stable alkaline phosphatase).
Histological and histochemical changes indicating an increased activity have been found in the placenta, particularly in the syncytiotrophoblast of women with a normal and threatened pregnancy, treated with allylestrenol. The stimulatory effect of allylestrenol on placental function was also suggested by the increased level of placental hormones (pregnanediol, oestriol, HCG and HPL) and enzymes (oxytocinase, CAP) in the maternal urine and plasma, which followed the administration of the drug e.g. in the early weeks as well as in the last trimester of pregnancy.
A study in full-term pregnant women revealed that allylestrenol in high doses (up to 100 mg daily) did suppress the intensity of spontaneous uterine contractions, but had no effect on the sensitivity of the uterine muscle to oxytocin, and no adverse effect on the progress of normal delivery.
Studies in non-pregnant women with and without endocrinological disorders have shown that allylestrenol has no oestrogenic or androgenic properties and no adverse effects on the adrenal function.
No abnormal liver function tests or water and salt retention were observed in healthy female volunteers (non pregnant) who were given allylestrenol.
DosageView
Intra Uterine Growth Retardation: 1 tablet three times a day at least two months. Dose to be reduced if symptoms improve.
Threatened abortion: 1 tablet three times daily until symptoms disappear.
Habitual abortion: 1-2 tablets daily as soon as pregnancy is diagnosed. The administration should be continued for at least one month after the end of the critical period.
Threatened premature delivery: Dosage must be determined individually. High dosages (up to 40 mg daily) have been used.
In case of a missed dose, it should be taken as soon as the patient remembers & she should continue the regular dosing schedule. A double dose is not recommended.
Threatened abortion: 1 tablet three times daily until symptoms disappear.
Habitual abortion: 1-2 tablets daily as soon as pregnancy is diagnosed. The administration should be continued for at least one month after the end of the critical period.
Threatened premature delivery: Dosage must be determined individually. High dosages (up to 40 mg daily) have been used.
In case of a missed dose, it should be taken as soon as the patient remembers & she should continue the regular dosing schedule. A double dose is not recommended.
Side effectsView
Treatment with Allylestrenol (especially a long term treatment) is known to cause some gastrointestinal complaints such as vomiting, nausea, and sometimes epigastric discomfort.
ContraindicationsView
- Breast Cancer or history of problem with the breasts like- Nodules,an abnormal Mammogram, or Fibrocystic Diseases.
- Severe liver disease such as Cholestatic Jaundice or Hepatitis, Hepatic Cell Tumours, Rotor Syndrome and Dubin Jhonson Syndrome.
- Undiagnosed vaginal bleeding
- Toxaemia of Pregnancy
- Crisis Seizures, Migraines
PrecautionsView
Patients with the following conditions should be cautious: Heart disease, congestive heart failure, sick sinus syndrome, coronary artery disease, seizures, epilepsy, renal dysfunction, migraine headaches, or breathing diseases including asthma, emphysema, chronic bronchitis, or COPD, breast-feeding.
Pregnancy & lactationView
Allylestrenol is specifically designed to be taken during pregnancy. It should be discontinued after delivery as it may affect a nursing infant to a small but noticeable degree.
Pediatric usageView
It should not be used for children younger than 16 years old.
Overdose effectsView
Symptoms of overdose may include unusual drowsiness; rapid pulse; fainting; unusual muscle movement or rigidity of the face, neck, or limbs; seizures; and loss of consciousness.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Getbion
Vitamin B1, B6 & B12
Getbion
Vitamin B1, B6 & B12
Indications
Vitamin B deficiencies
Indication detailsView
Vitamin B1, B6 & B12 is indicated for the treatment of vitamin B1, B6 & B12 deficiency syndrome. It is also indicated for the supportive treatment of neuritis & non-inflammatory diseases of the nerves, e.g.- Diabetic neuropathy, Peripheral neuralgin, Lumbago, Myalgia, Optic neuritis, Sciatica, Facial neuralgia, Intercostal neuralgia, Spinal pain.
Therapeutic classView
Specific combined vitamin preparations
PharmacologyView
Vitamin B1 converts carbohydrates, fatty acids and amino acids into energy, promotes healthy nerves, improves mood, strengthens the heart. Vitamin B6 forms RBCs, helps cells to make proteins, manufactures neurotransmitters e.g. serotonin and releases stored forms of energy, helps to prevent CVS diseases and stroke, helps to lift depression and eases insomnia. Vitamin B12 is essential for cell replication and important for RBC production, prevents anemia, helps to prevent depression, reduces nerve pain, numbness, tingling and lowers the risk of heart diseases.
The vitamin ingredients are absorbed well in per oral reception. It is widely distributed to most tissues and appears in breast milk. Within the cell, thiamine is mostly present as diphosphate. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or as metabolites. Pyridoxine, pyridoxal and pyridoxamine are readily absorbed from the GIT following oral administration and are converted to the active forms of pyridoxal phosphate an pyridoxamine phosphate. They are stored mainly in liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites, which are excreted in urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.
The vitamin ingredients are absorbed well in per oral reception. It is widely distributed to most tissues and appears in breast milk. Within the cell, thiamine is mostly present as diphosphate. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or as metabolites. Pyridoxine, pyridoxal and pyridoxamine are readily absorbed from the GIT following oral administration and are converted to the active forms of pyridoxal phosphate an pyridoxamine phosphate. They are stored mainly in liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites, which are excreted in urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.
DosageView
Tablet: 1-3 Tablets per day or as advised by the physician.
Injection:
Injection:
- In severe (acute) cases: 1 injection daily until the acute symptoms subside or taken as advised by the physician.
- In mild cases: 1 injection 2-3 times per week. Ampoules are preferably injected intramuscularly.
Side effectsView
Generally well tolerated but allergic reactions may be observed in few cases.
ContraindicationsView
Vitamin B1, Vitamin B6 and Vitamin B12 is contraindicated in patients on levodopa therapy, and in patients with hypersensitivity to any of the ingredients of the preparation.
PrecautionsView
Cyanocobalamin should not be given in patients with subacute degeneration of the spinal cord. Cyanocobalamin is not suitable form of vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.
InteractionsView
No drug interaction has been reported yet.
Pregnancy & lactationView
Oral tablet form is recommended but due to the presence of benzyl alcohol, injection is not recommended during pregnancy & lactation.
Overdose effectsView
No overdosage symptoms are to be expected in the recommended dosage. If there is known overdose then treatment is symptomatic & supportive.
StorageView
Keep out of reach of children. Store in a cool (below 25°C temperature) and dry place, protected from light.
Getinib
Gefitinib
Getinib
Gefitinib
Indications
Non-small cell lung cancer
Indication detailsView
Gefitinib is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Limitation of Use: Safety and efficacy of Gefitinib have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.
Limitation of Use: Safety and efficacy of Gefitinib have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.
Therapeutic classView
Targeted Cancer Therapy
PharmacologyView
Gefitinib inhibits the epidermal growth factor receptor (EGFR) tyrosine kinase by binding to the adenosine triphosphate (ATP)-binding site of the enzyme. Thus the function of the EGFR tyrosine kinase in activating the Ras signal transduction cascade is inhibited; and malignant cells are inhibited. Gefitinib is the first selective inhibitor of the EGFR tyrosine kinase which is also referred to as Her1 or ErbB-1. EGFR is overexpressed in the cells of certain types of human carcinomas - for example in lung and breast cancers. Overexpression leads to inappropriate activation of the apoptotic Ras signal transduction cascade, eventually leading to uncontrolled cell proliferation.
DosageView
The recommended dose of Gefitinib is 250 mg orally once daily with or without food until disease progression or unacceptable toxicity. Do not take a missed dose within 12 hours of the next dose.
Side effectsView
Common side effects are pruritus, rash, angioedema, urticaria, epistaxis, haematuria, alopecia, dry mouth and skin, nausea, vomiting, anorexia, stomatitis, diarrhoea, nail disorders, asthenia, pyrexia, proteinuria, eye pain, corneal erosion or ulcer, aberrant eyelash growth and elevations in blood creatinine. Rarely, pancreatitis, erythema multiforme, toxic epidermal necrolysis, corneal membrane sloughing, ocular ischemia, or ocular haemorrhage.
ContraindicationsView
Hypersensitivity. Lactation.
PrecautionsView
Interstitial lung disease (ILD): ILD occurred in patients taking Gefitinib. Gefitinib should be withheld for worsening of respiratory symptoms. It should be discontinued if ILD is confirmed.
Hepatotoxicity: Periodic liver function testing should be performed. Gefitinib should be withheld for Grade 2 or higher for ALT and/or AST elevations. It should be discontinued for severe hepatic impairment.
Gastrointestinal perforation: Gefitinib should be discontinued for gastrointestinal perforation.
Diarrhea: Gefitinib should be withheld for Grade 3 or higher diarrhea.
Ocular Disorders including Keratitis: Gefitinib should be withheld for signs and symptoms of severe or worsening ocular disorders including keratitis. It should be discontinued for persistent ulcerative keratitis.
Bullous and Exfoliative Skin Disorders: Gefitinib should be withheld for Grade 3 or higher skin reactions or exfoliative conditions.
Embryo-fetal Toxicity: Gefitinib can cause fetal harm. Potential risk of Gefitinib to a fetus should be advised and effective contraception should be used.
Hepatotoxicity: Periodic liver function testing should be performed. Gefitinib should be withheld for Grade 2 or higher for ALT and/or AST elevations. It should be discontinued for severe hepatic impairment.
Gastrointestinal perforation: Gefitinib should be discontinued for gastrointestinal perforation.
Diarrhea: Gefitinib should be withheld for Grade 3 or higher diarrhea.
Ocular Disorders including Keratitis: Gefitinib should be withheld for signs and symptoms of severe or worsening ocular disorders including keratitis. It should be discontinued for persistent ulcerative keratitis.
Bullous and Exfoliative Skin Disorders: Gefitinib should be withheld for Grade 3 or higher skin reactions or exfoliative conditions.
Embryo-fetal Toxicity: Gefitinib can cause fetal harm. Potential risk of Gefitinib to a fetus should be advised and effective contraception should be used.
InteractionsView
Concomitant use with CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, barbiturates) may reduce serum gefitinib levels. Plasma concentrations may be increased with potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole). Increased INR or bleeding events with warfarin. May increase plasma levels of metoprolol. May exacerbate vinorelbine-induced neutropenia. Decreased plasma levels and potential reduction in efficacy with drugs that affect gastric pH (e.g. PPIs, H2-receptor antagonists).
Pregnancy & lactationView
Pregnancy category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Pediatric usageView
Pediatric Use: The safety and effectiveness of Gefitinib in pediatric patients have not been established.
Geriatric Use: No overall differences in safety were observed between patients 65 years and older and those younger than 65 years. There is insufficient information to assess for differences in efficacy between older and younger patients.
Administration to patients who have difficulty swallowing solids: Immerse Gefitinib tablets in 4 to 8 ounces of water by dropping the tablet in water, and stir for approximately 15 minutes. Immediately drink the liquid or administer through a naso-gastric tube. Rinse the container with 4 to 8 ounces of water and immediately drink or administer through the naso-gastric tube.
Geriatric Use: No overall differences in safety were observed between patients 65 years and older and those younger than 65 years. There is insufficient information to assess for differences in efficacy between older and younger patients.
Administration to patients who have difficulty swallowing solids: Immerse Gefitinib tablets in 4 to 8 ounces of water by dropping the tablet in water, and stir for approximately 15 minutes. Immediately drink the liquid or administer through a naso-gastric tube. Rinse the container with 4 to 8 ounces of water and immediately drink or administer through the naso-gastric tube.
StorageView
Store between 20-25° C.
Giane
Cyproterone Acetate + Ethinyl Estradiol
Giane
Cyproterone Acetate + Ethinyl Estradiol
Indications
Prostate carcinoma
Indication detailsView
For the treatment of women with severe acne, unresponsive to oral antibiotic and other available treatments, with associated symptoms of androgenization, including seborrhea and mild hirsutism.
Therapeutic classView
Oral Contraceptive preparations, Oral Hormonal preparations for Acne
PharmacologyView
Cyproterone is a steroid compound with potent antiandrogenic, progestogenic and antigonadotrophic activity. It exerts its antiandrogenic effect by blocking androgen receptors. It also reduces androgen synthesis by a negative feedback effect on the hypothalamo-pituitary-ovarian systems. The estrogen component (Ethinylestradiol) increases levels of sex hormone binding globulin (SHBG) and thus reduces the free circulating plasma levels of androgens. Cyproterone has no tendency to reduce SHBG levels.
If used alone in women,Cyproterone leads to menstrual cycle disturbances which are avoided when combined with Ethinylestradiol. When this tablet is administered in a cyclic manner, it has the added effect of preventing ovulation and possible conception.
The components of this tablet are rapidly absorbed after oral administration. Due to the long terminal half-life of Cyproterone, a 4-fold increase in plasma levels occurs after 6 to 12 days of daily dosing. Long-term therapy (36 months) with this product did not have a significant influence on lipid metabolism. A trend to increase plasma cholesterol and triglyceride levels was observed. There was a slight decrease in low density lipoprotein (LDL) with a simultaneous increase in high density lipoprotein (HDL).
If used alone in women,Cyproterone leads to menstrual cycle disturbances which are avoided when combined with Ethinylestradiol. When this tablet is administered in a cyclic manner, it has the added effect of preventing ovulation and possible conception.
The components of this tablet are rapidly absorbed after oral administration. Due to the long terminal half-life of Cyproterone, a 4-fold increase in plasma levels occurs after 6 to 12 days of daily dosing. Long-term therapy (36 months) with this product did not have a significant influence on lipid metabolism. A trend to increase plasma cholesterol and triglyceride levels was observed. There was a slight decrease in low density lipoprotein (LDL) with a simultaneous increase in high density lipoprotein (HDL).
DosageView
This tablet should not be prescribed solely for its contraceptive properties. If patient compliance is uncertain and contraception is necessary, then a supplementary nonhormonal contraceptive method should be considered.
First Treatment Course: The patient is instructed to take 1 tablet daily for 21 consecutive days beginning on day 1 of her menstrual cycle. (For the first cycle only the first day of menstrual flow is considered Day 1). The tablets are then discontinued for 7 days (1 week). Withdrawal bleeding should usually occur during the period that the patient is off the tablets.The first cycle will be somewhat shorter than usual, whereas all following cycles will last 4 weeks. The patient should be instructed to take the first tablet from the blister pack out of the section marked with the corresponding day (for example "Mon" for Monday) of the week and swallow it with some liquid. The patient should be instructed to take the tablet at the same time each day.
Subsequent Courses: The patient begins her next and all subsequent 21-day course of tablets (following the same 21 days on, 7 days off) on the same day of the week that she began her first course. She begins taking her tablets 7 days after discontinuation,regardless of whether or not withdrawal bleeding is still in progress.
Treatment should be continued for several months,since improvement may not be observed for at least 3 months. The need to continue treatment with This tablet should be evaluated periodically by the treating physician. This drug should be discontinued 3 to 4 cycles after signs have completely resolved.
Pregnancy should be ruled out before continuing treatment with This tablet in patients who have missed a menstrual period, if pregnancy is suspected, medication should be discontinued.
Missed dose: If the patient forgets to take a tablet at the usual time, the tablet may be taken within the next 12 hours. If more than 12 hours have elapsed from the time of usual administration, the patient must discard the missed tablet and continue to take the remaining tablets in the pack at the usual time in order to avoid premature withdrawal bleeding during this cycle. A supplementary nonhormonal method of contraception must be employed until the pack is empty to prevent pregnancy which would necessitate immediate discontinuation of this treatment.
First Treatment Course: The patient is instructed to take 1 tablet daily for 21 consecutive days beginning on day 1 of her menstrual cycle. (For the first cycle only the first day of menstrual flow is considered Day 1). The tablets are then discontinued for 7 days (1 week). Withdrawal bleeding should usually occur during the period that the patient is off the tablets.The first cycle will be somewhat shorter than usual, whereas all following cycles will last 4 weeks. The patient should be instructed to take the first tablet from the blister pack out of the section marked with the corresponding day (for example "Mon" for Monday) of the week and swallow it with some liquid. The patient should be instructed to take the tablet at the same time each day.
Subsequent Courses: The patient begins her next and all subsequent 21-day course of tablets (following the same 21 days on, 7 days off) on the same day of the week that she began her first course. She begins taking her tablets 7 days after discontinuation,regardless of whether or not withdrawal bleeding is still in progress.
Treatment should be continued for several months,since improvement may not be observed for at least 3 months. The need to continue treatment with This tablet should be evaluated periodically by the treating physician. This drug should be discontinued 3 to 4 cycles after signs have completely resolved.
Pregnancy should be ruled out before continuing treatment with This tablet in patients who have missed a menstrual period, if pregnancy is suspected, medication should be discontinued.
Missed dose: If the patient forgets to take a tablet at the usual time, the tablet may be taken within the next 12 hours. If more than 12 hours have elapsed from the time of usual administration, the patient must discard the missed tablet and continue to take the remaining tablets in the pack at the usual time in order to avoid premature withdrawal bleeding during this cycle. A supplementary nonhormonal method of contraception must be employed until the pack is empty to prevent pregnancy which would necessitate immediate discontinuation of this treatment.
Side effectsView
Common side effects are Bleeding, Dizziness, Depression, Weight gain, Headache, Edema, Breast pain, Lactation, Blood clot, Gallstones.
.
.
ContraindicationsView
- Thrombophlebitis, thromboembolic disorders, or a history of these conditions
- Cerebrovascular disorders
- Myocardial infarction or coronary artery diseases
- Active liver disease or hepatic adenomas or carcinomas
- History of cholestatic jaundice
- Known or suspected carcinoma of the breast
- Known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal vaginal bleeding
- Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields
- When pregnancy is suspected or diagnosed
- Previous or existing liver tumors
- Severe diabetes with vascular changes
- A history of otosclerosis with deterioration during pregnancy.
PrecautionsView
Predisposing Factors for Coronary Artery Diseases: In women with predisposing factors for coronary artery disease (such as cigarette smoking, hypertension; hypercholesterolemia, obesity, diabetes and increasing age), the use of estrogen or progestogen combinations have been reported as an additional risk factor. After the age of 35 years, estrogen or progestogen combinations should be considered only in exceptional circumstances and when the risk/benefit ratio has been carefully weighed by both the patient and the physician. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from the use of this class of medication. This risk increases with age and heavy smoking (15 or more cigarettes per day) and is more marked in women over 35 years of age. Women who use such medication should not smoke. Estrogen/progestogen combinations may cause an increase in plasma lipoproteins and should be administered with caution to women known to have pre-existent hyperlipoproteinemia. Lipid profiles should be determined regularly in these patients. The combination of obesity, hypertension and diabetes is particularly hazardous to women who are taking this class of medication. To avoid this triad of conditions develop, the patient should be placed on an alternate form of therapy.
Discontinue medication at the earliest manifestation of: Thromboembolic and cardiovascular disorders such as: thrombophlebitis, pulmonary embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis and retinal thrombosis. The use of estrogen/progestogen-combination products should be avoided in conditions which predispose to venous stasis and to vascular thrombosis, e.g. immobilization after accidents or confinement to bed during long-term illness. Under such conditions other nonhormonal methods of treatment should be considered. For use when surgery is contemplated, see Precautions.
Migraine and Headache: The onset or exacerbation of migraine or the development of headache of a new pattern which is recurrent persistent or severe, requires discontinuation of medication and evaluation of the cause.
Diabetes: Diabetic patients, or those with a family history of diabetes, should be observed closely to detect any alterations in carbohydrate metabolism. Patients predisposed to diabetes who can be kept under close supervision may be given estrogen/progestogen combinations under strict medical supervision. Young diabetic patients whose disease is of recent origin, well-controlled, and not associated with hypertension or other signs of vascular disease such as ocular fundal changes should be closely observed.
Discontinue medication at the earliest manifestation of: Thromboembolic and cardiovascular disorders such as: thrombophlebitis, pulmonary embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis and retinal thrombosis. The use of estrogen/progestogen-combination products should be avoided in conditions which predispose to venous stasis and to vascular thrombosis, e.g. immobilization after accidents or confinement to bed during long-term illness. Under such conditions other nonhormonal methods of treatment should be considered. For use when surgery is contemplated, see Precautions.
- Visual defects, partial or complete.
- Papilledema, or ophthalmic vascular lesions.
- Severe headache of unknown etiology, or worsening of pre-existing migraine headache.
- Onset of jaundice or hepatitis.
- Itching of the whole body.
Migraine and Headache: The onset or exacerbation of migraine or the development of headache of a new pattern which is recurrent persistent or severe, requires discontinuation of medication and evaluation of the cause.
Diabetes: Diabetic patients, or those with a family history of diabetes, should be observed closely to detect any alterations in carbohydrate metabolism. Patients predisposed to diabetes who can be kept under close supervision may be given estrogen/progestogen combinations under strict medical supervision. Young diabetic patients whose disease is of recent origin, well-controlled, and not associated with hypertension or other signs of vascular disease such as ocular fundal changes should be closely observed.
InteractionsView
Concurrent use of the following drugs may result in reduced efficacy of this tablet and increased incidence of breakthrough bleeding: Ampicillin, Analgesics, Antihistamines, Antimigraine preparations, Chloramphenicol, Griseofulvin, Isoniazid, Neomycin, Nitrofurantain, Penicillin V, Phenylbutazone, Sulfonamides and Tetracycline.
Concurrent use of anticoagulants with estrogen/progestogen combinations may reduce the anticoagulant effect. Effectiveness of the following drugs may be altered when used concurrently: Antihypertensive, Benzodiazepines (those that undergo oxidative degradation), Beta-adrenergic blockers,Caffeine, Corticosteroids, Hypoglycemic, Phenothiazine, Theophylline, Tricyclic antidepressants and Vitamins.
Concurrent use of the following drugs may reduce the efficacy of this tablet because of accelerated estrogen metabolism caused by the induction of hepatic enzymes: Carbamazepine, Phenobarbital, Phenytoin, Pyrimidine and Rifampicin.
Diabetics using estrogen/progestogen combinations may require adjustment of their antidiabetic medication. Concurrent administration of vitamin C (ascorbic acid) with estrogen/ progestogen combinations has been reported to result in a significant rise in plasma Ethinylestradiol levels.
Rule out pregnancy before treatment is begun. Because of the antiandrogenic action of this tablet,feminization of male fetuses has occurred in animal studies and may possibly occur in humans.
Concurrent use of anticoagulants with estrogen/progestogen combinations may reduce the anticoagulant effect. Effectiveness of the following drugs may be altered when used concurrently: Antihypertensive, Benzodiazepines (those that undergo oxidative degradation), Beta-adrenergic blockers,Caffeine, Corticosteroids, Hypoglycemic, Phenothiazine, Theophylline, Tricyclic antidepressants and Vitamins.
Concurrent use of the following drugs may reduce the efficacy of this tablet because of accelerated estrogen metabolism caused by the induction of hepatic enzymes: Carbamazepine, Phenobarbital, Phenytoin, Pyrimidine and Rifampicin.
Diabetics using estrogen/progestogen combinations may require adjustment of their antidiabetic medication. Concurrent administration of vitamin C (ascorbic acid) with estrogen/ progestogen combinations has been reported to result in a significant rise in plasma Ethinylestradiol levels.
Rule out pregnancy before treatment is begun. Because of the antiandrogenic action of this tablet,feminization of male fetuses has occurred in animal studies and may possibly occur in humans.
Pregnancy & lactationView
Fetal abnormalities have been reported to occur in the offspring of women who have taken estrogen/progestogen combinations in early pregnancy. Rule out pregnancy as soon as it is suspected. The use of estrogen/progestogen combinations during the period a mother is breast-feeding her infant may not be advisable. The hormonal components are excreted in breast milk and may reduce its quantity and quality. The long-term effects on the developing child are not known. This drug may cause fluid retention, conditions such as epilepsy.
Overdose effectsView
Symptoms and Treatment:There have been no reports of overdose with this tablet. There are no specific antidotes and treatment should be symptomatic, based on the knowledge of the pharmacological action of the constituents.
StorageView
Store below 30°C and in dry place. Protect from light. Keep out of the reach of children.
Gide
Gliclazide
Gide
Gliclazide
Indications
Type 2 DM
Indication detailsView
Gliclazide is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group). Gliclazide is used in a certain form of diabetes (type 2 diabetes Mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.
Therapeutic classView
Sulfonylureas
PharmacologyView
Gliclazide is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful hematological properties. It stimulates the release of insulin from pancreatic β-cells by facilitating Ca+2 transport across the β-cell membranes and decreases hepatic glucose output.
DosageView
Film-coated tablet: The usual initial dose is 40 to 80 mg daily. The dose can be increased up to 320 mg daily in divided doses when needed. The drug should be taken before meal. For children, Gliclazide is not used because it is contraindicated in juvenile-onset diabetes.
Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).
If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).
If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Side effectsView
Like all medicines, Gliclazide can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycaemia). If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.
Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.
Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.
Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
ContraindicationsView
Do not take Gliclazide:
- if you are allergic to gliclazide or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic sulfonamides)
- if you have insulin-dependent diabetes (type 1)
- if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma
- if you have severe kidney or liver disease
- if you are taking medicines to treat fungal infections
- if you are breastfeeding
PrecautionsView
Talk to your doctor before taking Gliclazide. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.
Low blood sugar (Hypoglycaemia) may occur:
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).
If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.
Gliclazide is not recommended for use in children due to lack of data.
Low blood sugar (Hypoglycaemia) may occur:
- if you take meals irregularly or skip meals altogether,
- if you are fasting
- if you are malnourished
- if you change your diet
- if you increase your physical activity and carbohydrate intake does not match this increase,
- if you drink alcohol, especially in combination with skipped meals,
- if you take other medicines or natural remedies at the same time,
- if you take too high doses of gliclazide,
- if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex),
- if your kidney function or liver function is severely decreased.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).
If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.
Gliclazide is not recommended for use in children due to lack of data.
InteractionsView
Other medicines and Gliclazide: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:
Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.
Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:
- other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
- antibiotics (sulphonamides, clarithromycin)
- medicines to treat high blood pressure or heart failure (beta-blockers. ACE-inhibitors such as captopril, or enalapril)
- medicines to treat fungal infections (miconazole, fluconazole)
- medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
- medicines to treat depression (monoamine oxidase inhibitors)
- painkiller or antirheumatics (phenylbutazone, ibuprofen)
- medicines containing alcohol
- medicines to treat disorders of the central nervous system (chlorpromazine)
- medicines reducing inflammation (corticosteroids)
- medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline)
- medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol)
- St John's Wort- Hypericum perforatum- preparations
Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.
Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
- have frequent episodes of low blood sugar (hypoglycaemia)
- have few or no warning signals of low blood sugar (hypoglycaemia)
Pregnancy & lactationView
Gliclazide is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You must not take Gliclazide while you are breastfeeding.
StorageView
Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Store below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Gidonic
Domperidone Maleate
Gidonic
Domperidone Maleate
Indications
Vomiting
Indication detailsView
Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
- Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
- Eructation, flatulence, early satiety
- Nausea and vomiting
- Heartburn with or without regurgitations of gastric contents in the mouth
- Non-ulcer dyspepsia
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
Therapeutic classView
Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs
PharmacologyView
Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.
DosageView
Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.
The usual recommended oral dose of Domperidone is as follows:
The usual recommended oral dose of Domperidone is as follows:
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
- Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.
- Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).
- Adults (including elderly): 30-60 mg every 4-8 hours.
- Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
- The maximum period of treatment is 12 weeks.
Side effectsView
Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.
ContraindicationsView
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).
PrecautionsView
Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.
InteractionsView
Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.
Pregnancy & lactationView
The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
Overdose effectsView
There are no reported cases of overdose.
StorageView
Store below 30°C, Protected from light & moisture. Keep out of children's reach.
Gidonic
Domperidone Maleate
Gidonic
Domperidone Maleate
Indications
Vomiting
Indication detailsView
Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
- Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
- Eructation, flatulence, early satiety
- Nausea and vomiting
- Heartburn with or without regurgitations of gastric contents in the mouth
- Non-ulcer dyspepsia
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
Therapeutic classView
Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs
PharmacologyView
Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.
DosageView
Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.
The usual recommended oral dose of Domperidone is as follows:
The usual recommended oral dose of Domperidone is as follows:
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
- Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.
- Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).
- Adults (including elderly): 30-60 mg every 4-8 hours.
- Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
- The maximum period of treatment is 12 weeks.
Side effectsView
Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.
ContraindicationsView
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).
PrecautionsView
Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.
InteractionsView
Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.
Pregnancy & lactationView
The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
Overdose effectsView
There are no reported cases of overdose.
StorageView
Store below 30°C, Protected from light & moisture. Keep out of children's reach.
Gidora
Domperidone Maleate
Gidora
Domperidone Maleate
Indications
Vomiting
Indication detailsView
Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
- Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
- Eructation, flatulence, early satiety
- Nausea and vomiting
- Heartburn with or without regurgitations of gastric contents in the mouth
- Non-ulcer dyspepsia
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
Therapeutic classView
Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs
PharmacologyView
Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.
DosageView
Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.
The usual recommended oral dose of Domperidone is as follows:
The usual recommended oral dose of Domperidone is as follows:
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
- Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.
- Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).
- Adults (including elderly): 30-60 mg every 4-8 hours.
- Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
- The maximum period of treatment is 12 weeks.
Side effectsView
Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.
ContraindicationsView
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).
PrecautionsView
Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.
InteractionsView
Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.
Pregnancy & lactationView
The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
Overdose effectsView
There are no reported cases of overdose.
StorageView
Store below 30°C, Protected from light & moisture. Keep out of children's reach.
Gidora
Domperidone Maleate
Gidora
Domperidone Maleate
Indications
Vomiting
Indication detailsView
Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
- Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
- Eructation, flatulence, early satiety
- Nausea and vomiting
- Heartburn with or without regurgitations of gastric contents in the mouth
- Non-ulcer dyspepsia
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
Therapeutic classView
Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs
PharmacologyView
Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.
DosageView
Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.
The usual recommended oral dose of Domperidone is as follows:
The usual recommended oral dose of Domperidone is as follows:
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
- Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.
- Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).
- Adults (including elderly): 30-60 mg every 4-8 hours.
- Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
- The maximum period of treatment is 12 weeks.
Side effectsView
Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.
ContraindicationsView
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).
PrecautionsView
Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.
InteractionsView
Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.
Pregnancy & lactationView
The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
Overdose effectsView
There are no reported cases of overdose.
StorageView
Store below 30°C, Protected from light & moisture. Keep out of children's reach.
Gifon
Glimepiride
Gifon
Glimepiride
Indications
Type 2 DM
Indication detailsView
Glimepiride is indicated in following conditions-
- Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycaemia cannot be controlled by diet and exercise alone.
- Glimepiride may be used concomitantly with metformin when diet, exercise, and Glimepiride or metformin alone does not result in adequate glycaemic control.
- Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycaemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycaemic agent.
- Combined use of Glimepiride and insulin may increase the potential for hypoglycaemia.
Therapeutic classView
Sulfonylureas
PharmacologyView
Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion. In addition, extrapancreatic effects like reduction of basal hepatic glucose production, increased peripheral tissue sensitivity to insulin and glucose uptake may also play role in the activity of Glimepiride. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.
DosageView
In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride must be the lowest which is sufficient to achieve the desired metabolic control. The initial and the maintenance doses are set based on the results of regular check of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
AdministrationView
Glimepiride tablet must be swallowed with sufficient amount of liquid.
Side effectsView
Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure.
ContraindicationsView
Glimepiride is not suitable for the treatment of insulin dependent (type I) diabetes mellitus, or for the treatment of diabetic ketoacidosis, nor for the treatment of diabetic coma. Glimepiride must not be used in patients hypersensitive to Glimepiride, other sulfonylureas, other sulfonamides, severe hepatic dysfunction, severe impairment of renal function and dialysis patients.
PrecautionsView
in the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring. If such risk present it may be necessary to adjust the dosage of Glimepiride, Hypoglycaemia can almost be promptly controlled by immediate intake of carbohydrates (glucose or sugar).
InteractionsView
Based on experience with Glimepiride and known interactions for other sulfonylureas, the following interactions must be considered.
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
- Acetazoiamide, barbiturates, calcium channel blockers, corticosteroids, diazoxide, diuretics, glucagon, isoniazid, laxatives, nicotinic acid (high doses), oestrogens, phenothiazines, phenytoin, progestagens, rifampicin, sympathomimetic agents, thyroid hormones.
- H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering effect.
- Concomitant treatment with a beta-receptor blocker, clonidine, guanethidine or reserpine may mask the warning symptoms of a hypoglycaemic attack.
- Acute and chronic aicohol intake may either potentiate or attenuate the activity of Glimepiride in an unpredictable fashion.
Pregnancy & lactationView
Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician, and should change over to insulin. Ingestion of Glimepiride with breast milk feeding may harm the child. Therefore, Glimepiride must not be taken by breastfeeding women. Either a changeover or complete discontinuation of breastfeeding is necessary.
Overdose effectsView
Overdosage of sulfonylureas, including Glimepiride, can produce hypoglycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medicai emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycaemia may recur after apparent clinical recovery.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Gifon
Glimepiride
Gifon
Glimepiride
Indications
Type 2 DM
Indication detailsView
Glimepiride is indicated in following conditions-
- Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycaemia cannot be controlled by diet and exercise alone.
- Glimepiride may be used concomitantly with metformin when diet, exercise, and Glimepiride or metformin alone does not result in adequate glycaemic control.
- Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycaemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycaemic agent.
- Combined use of Glimepiride and insulin may increase the potential for hypoglycaemia.
Therapeutic classView
Sulfonylureas
PharmacologyView
Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion. In addition, extrapancreatic effects like reduction of basal hepatic glucose production, increased peripheral tissue sensitivity to insulin and glucose uptake may also play role in the activity of Glimepiride. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.
DosageView
In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride must be the lowest which is sufficient to achieve the desired metabolic control. The initial and the maintenance doses are set based on the results of regular check of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
AdministrationView
Glimepiride tablet must be swallowed with sufficient amount of liquid.
Side effectsView
Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure.
ContraindicationsView
Glimepiride is not suitable for the treatment of insulin dependent (type I) diabetes mellitus, or for the treatment of diabetic ketoacidosis, nor for the treatment of diabetic coma. Glimepiride must not be used in patients hypersensitive to Glimepiride, other sulfonylureas, other sulfonamides, severe hepatic dysfunction, severe impairment of renal function and dialysis patients.
PrecautionsView
in the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring. If such risk present it may be necessary to adjust the dosage of Glimepiride, Hypoglycaemia can almost be promptly controlled by immediate intake of carbohydrates (glucose or sugar).
InteractionsView
Based on experience with Glimepiride and known interactions for other sulfonylureas, the following interactions must be considered.
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
- Acetazoiamide, barbiturates, calcium channel blockers, corticosteroids, diazoxide, diuretics, glucagon, isoniazid, laxatives, nicotinic acid (high doses), oestrogens, phenothiazines, phenytoin, progestagens, rifampicin, sympathomimetic agents, thyroid hormones.
- H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering effect.
- Concomitant treatment with a beta-receptor blocker, clonidine, guanethidine or reserpine may mask the warning symptoms of a hypoglycaemic attack.
- Acute and chronic aicohol intake may either potentiate or attenuate the activity of Glimepiride in an unpredictable fashion.
Pregnancy & lactationView
Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician, and should change over to insulin. Ingestion of Glimepiride with breast milk feeding may harm the child. Therefore, Glimepiride must not be taken by breastfeeding women. Either a changeover or complete discontinuation of breastfeeding is necessary.
Overdose effectsView
Overdosage of sulfonylureas, including Glimepiride, can produce hypoglycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medicai emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycaemia may recur after apparent clinical recovery.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.