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Contact Information
Registered Office/ Head Office:
Ashford Laboratories Pvt. Ltd.,
31/36, 5th Floor, Dheeraj Heritage,
S. V. Road, Santacruz (West),
Mumbai (Bombay) - 400 054. India.
Tele- fax: + 91 22 6675 8866
Email:info@ashfordlab.com
Japan Office:
Ashford Laboratories,
4-11-24-1402 Fukae Kitamachi,
Higashi Nada Ku, Kobe 658-0013,
Japan.
Tele- fax: +81 0784 122579
Email:japan@ashfordlab.com
Ashford Laboratories Pvt. Ltd.,
31/36, 5th Floor, Dheeraj Heritage,
S. V. Road, Santacruz (West),
Mumbai (Bombay) - 400 054. India.
Tele- fax: + 91 22 6675 8866
Email:info@ashfordlab.com
Japan Office:
Ashford Laboratories,
4-11-24-1402 Fukae Kitamachi,
Higashi Nada Ku, Kobe 658-0013,
Japan.
Tele- fax: +81 0784 122579
Email:japan@ashfordlab.com
Contraceptive Drugs
TOPLivenofear™ (Levonorgestrel 1.5 mg)
Levonorgestrel 1.5mg Tablets
PHARMACEUTICAL FORM
Tablet. The tablet is round and white.
CLINICAL PARTICULARS
Therapeutic indications
Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method. Livenofear is not recommended for use by young women under 16 years of age without medical supervision.
Posology and method of administration
For oral administration
One tablet should be taken as soon as possible, preferably within 12 hours and no later than 72 hours after unprotected intercourse.
If vomiting occurs within three hours of taking the tablet another tablet should be taken immediately. The patient should contact her doctor, family planning clinic or pharmacist for advice and another tablet.
Livenofear can be used at any time during the menstrual cycle unless menstrual bleeding is overdue.
After using emergency contraception it is recommended to use a barrier method (e.g. condom, diaphragm or cap) until the next menstrual period starts. The use of Livenofear does not contraindicate the continuation of regular hormonal contraception.
Children
Livenofear is not recommended for use by young women under 16 years of age without medical supervision.
Contraindications
Hypersensitivity to the active substance levonorgestrel or any of the excipients.
Overdose
Serious undesirable effects have not been reported following acute ingestion of large doses of oral contraceptives. Overdose may cause nausea, and withdrawal bleeding may occur. There are no specific antidotes and treatment should be symptomatic.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
PROGESTOGENS
G03AC03
The precise mode of action of Livenofear is not known.
At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest. It may also cause endometrial changes that discourage implantation. Livenofear is not effective once the process of implantation has begun.
Efficacy
Results from a recent clinical study (Lancet 2002; 360: 1803-1810) showed that a 1500 microgram single dose of Livenofear (taken within 72 hours of unprotected sex) prevented 84% of expected pregnancies (compared with 79% when the two 750 microgram tablets were taken 12 hours apart).
At the recommended regimen, levonorgestrel is not expected to induce significant modification of blood clotting factors, and lipid and carbohydrate metabolism.
Pharmacokinetic properties
Levonorgestrel
orally administered levonorgestrel is rapidly and almost completely absorbed. The absolute bioavailability of levonorgestrel was determined to be almost 100% of the dose administered. About 0.1% of the maternal dose can be transferred via milk to the nursed infant.
PHARMACEUTICAL PARTICULARS
List of excipients
Potato starch, Maize starch, Colloidal silica anhydrous, Magnesium stearate, Talc, Lactose monohydrate.
Shelf life
4 years
Special precautions for storage
Store in original container in order to protect from light.
Nature and contents of container
PVC/ Aluminum-blister containing one tablet. The blister is packaged in a folded carton.
TOPOptiNor 350™ (Norethisterone 350 mcg) Norethisterone 0.35mg Tablets PHARMACEUTICAL FORM
White, flat, circular, bevel-edged tablet.
CLINICAL PARTICULARS
Therapeutic indications
Optinor 350 is a progestogen-only oral contraceptive. It is particularly useful for women for whom oestrogens may not be appropriate.
Posology and method of administration
Oral Administration
Starting on the first day of menstruation, one pill every day without a break in medication for as long as contraception is required. Additional contraceptive precautions (such as a condom) should be taken for the first 7 days of the first pack. Pills should be taken at the same time each day.
Missed Pills
If a pill is missed within 3 hours of the correct dosage time then the missed pill should be taken as soon as possible; this will ensure that contraceptive protection is maintained. If a pill is taken 3 or more hours late it is recommended that the woman takes the last missed pill as soon as possible and then continues to take the rest of the pills in the normal manner. However, to provide continued contraceptive protection it is recommended that an alternative method of contraception, such as a condom, is used for the next 7 days.
Changing from another oral contraceptive
In order to ensure that contraception is maintained it is advised that the first pill is taken on the day immediately after the patient has finished the previous pack.
Use after childbirth, miscarriage or abortion
The first pill should be taken on the 21st day after childbirth. This will ensure the patient is protected immediately. If there is any delay in taking the first pill, contraception may not be established until 7 days after the first pill has been taken. In these circumstances women should be advised that extra contraceptive methods will be necessary.
After a miscarriage or abortion patients can take the first pill on the next day; in this way they will be protected immediately.
Vomiting and diarrhoea
Gastrointestinal upsets, such as vomiting and diarrhoea, may interfere with the absorption of the pill leading to a reduction in contraceptive efficacy. Women should continue to take Optinor 350, but they should also be advised to use another contraceptive method during the period of gastrointestinal upset and for the next 7 days.
Contraindications
The contraindications for progestogen-only oral contraceptives are
known, suspected, or a past history of breast, genital or hormone dependent cancer;
acute or severe chronic liver diseases including past or present liver tumours, Dubin-Johnson or Rotor syndrome;
active liver disease;
history during pregnancy of idiopathic jaundice or severe pruritus;
disorders of lipid metabolism;
undiagnosed abnormal vaginal bleeding ;
known or suspected pregnancy;
hypersensitivity to any component.
Pregnancy and lactation
Optinor 350 is contraindicated in women with suspected pregnancy. Several reports suggest an association between foetal exposure to female sex hormones, including oral contraceptives, and congenital anomalies.
There is no evidence that Optinor 350 tablets diminish the yield of breast milk. Small amounts of steroid materials appear in the milk; their effect on the breast-fed child has not been determined.
Overdose
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may be manifested by nausea, vomiting, breast enlargement and vaginal bleeding. There is no specific antidote and treatment should be symptomatic. Gastric lavage may be employed if the overdose is large and the patient is seen sufficiently early (within four hours).
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Norethisterone administration increases the protein and sialic acid content of cervical mucus which prevents penetration of the mucus by spermatozoa. It causes changes in the structure of the endometrium such that implantation of blastocysts is impaired. It also reduces numbers and height of cilia on cells lining the fallopian tube, which could delay tubal transport of ova.
PHARMACEUTICAL PARTICULARS
List of excipients
Maize starch, polyvidone, magnesium stearate and lactose. Shelf life
5 years
Special precautions for storage
Store in a cool, dry place away from direct sunlight.
Nature and contents of container
Optinor 350 tablets are supplied in pvc/foil blister packs of 28 and 84 tablets. Blister packaging consists of 250 micron PVC and 20 micron aluminium foil.
TOPProstoford 125™ (Carboprost tromethamine Inj. 125 mcg) Carboprost tromethamine Inj. TOPProstoford™ (Carboprost tromethamine Inj. 250 mcg) Carboprost tromethamine Inj. Each 1 ml contains carboprost tromethamine equivalent to carboprost 125 micrograms.
Each 1 ml contains carboprost tromethamine equivalent to carboprost 250 micrograms.
PHARMACEUTICAL FORM
Colourless, sterile, aqueous solution for intramuscular injection.
CLINICAL PARTICULARS
Therapeutic indications
Treatment of post-partum haemorrhage due to uterine atony and refractory to conventional methods of treatment with oxytocic agents and ergometrine used either alone or in combination.
Posology and method of administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
An initial dose of 250 micrograms (1.0 ml) of Hemabate should be administered as a deep intramuscular injection.
If necessary, further doses of 250 micrograms may be administered at intervals of approximately 1.5 hours. In severe cases the interval between doses may be reduced at the discretion of the attending physician, but it should not be less than 15 minutes. The total dose of Hemabate should not exceed 2 mg (8 doses).
Elderly
Not applicable
Children
Not applicable.
Contraindications
Hemabate should not be used where the patient is sensitive to carboprost tromethamine or any of the excipients.
Hemabate is not recommended in the following circumstances
Acute pelvic inflammatory disease.
Patients with known cardiac, pulmonary, renal or hepatic disease.
Pregnancy and lactation
Hemabate is contra-indicated in pregnancy. In the unlikely event of a mother breastfeeding her baby whilst receiving Hemabate, no adverse effects to the nursing infant would be anticipated.
Overdose
Treatment of overdosage must be symptomatic at this time, as clinical studies with prostaglandin antagonists have not progressed to the point where recommendations may be made.
If evidence of excessive side-effects appears, the frequency of administration should be decreased or administration discontinued.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Carboprost is a synthetic 15-methyl analogue of dinoprost (prostaglandin F2 alpha). It is a uterine stimulant with a more prolonged action than dinoprost and when used in post-partum haemorrhage, it stimulates the uterus to contract in a manner similar to that normally observed in the uterus following delivery. The resulting myometrial contractions provide haemostasis at the site of placentation and hence prevent further blood loss. Whether or not this action results from a direct effect on the myometrium has not been determined with certainty at this time. The fundamental actions of the prostaglandins include inhibition or stimulation of smooth muscle contraction and inhibition of the release of noradrenaline or modulation of its effects at neuroeffector sites. They affect the uterus, the cardiovascular system, the gastro-intestinal system, the nervous system, the urinary system and metabolic processes.
PHARMACEUTICAL PARTICULARS
List of excipients
Benzyl alcohol, Sodium chloride, Tromethamine, Sodium hydroxide, Hydrochloric acid, Water for injections
Shelf life
Ampoules: 48 months
Vial: 24 months
Special precautions for storage
The ampoules must be stored in a refrigerator at 2 - 8°C.
The vial must be stored in a refrigerator at 0 - 6°C
Nature and contents of container
Ampoule: Type 1 glass ampoule containing 1 ml solution, packed in cartons of two or ten ampoules.
Vial: Type 1 glass with butyl rubber closure, containing 10 ml solution, packed individually in a carton.
Tablet. The tablet is round and white.
CLINICAL PARTICULARS
Therapeutic indications
Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method. Livenofear is not recommended for use by young women under 16 years of age without medical supervision.
Posology and method of administration
For oral administration
One tablet should be taken as soon as possible, preferably within 12 hours and no later than 72 hours after unprotected intercourse.
If vomiting occurs within three hours of taking the tablet another tablet should be taken immediately. The patient should contact her doctor, family planning clinic or pharmacist for advice and another tablet.
Livenofear can be used at any time during the menstrual cycle unless menstrual bleeding is overdue.
After using emergency contraception it is recommended to use a barrier method (e.g. condom, diaphragm or cap) until the next menstrual period starts. The use of Livenofear does not contraindicate the continuation of regular hormonal contraception.
Children
Livenofear is not recommended for use by young women under 16 years of age without medical supervision.
Contraindications
Hypersensitivity to the active substance levonorgestrel or any of the excipients.
Overdose
Serious undesirable effects have not been reported following acute ingestion of large doses of oral contraceptives. Overdose may cause nausea, and withdrawal bleeding may occur. There are no specific antidotes and treatment should be symptomatic.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
PROGESTOGENS
G03AC03
The precise mode of action of Livenofear is not known.
At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest. It may also cause endometrial changes that discourage implantation. Livenofear is not effective once the process of implantation has begun.
Efficacy
Results from a recent clinical study (Lancet 2002; 360: 1803-1810) showed that a 1500 microgram single dose of Livenofear (taken within 72 hours of unprotected sex) prevented 84% of expected pregnancies (compared with 79% when the two 750 microgram tablets were taken 12 hours apart).
At the recommended regimen, levonorgestrel is not expected to induce significant modification of blood clotting factors, and lipid and carbohydrate metabolism.
Pharmacokinetic properties
Levonorgestrel
orally administered levonorgestrel is rapidly and almost completely absorbed. The absolute bioavailability of levonorgestrel was determined to be almost 100% of the dose administered. About 0.1% of the maternal dose can be transferred via milk to the nursed infant.
PHARMACEUTICAL PARTICULARS
List of excipients
Potato starch, Maize starch, Colloidal silica anhydrous, Magnesium stearate, Talc, Lactose monohydrate.
Shelf life
4 years
Special precautions for storage
Store in original container in order to protect from light.
Nature and contents of container
PVC/ Aluminum-blister containing one tablet. The blister is packaged in a folded carton.
TOPOptiNor 350™ (Norethisterone 350 mcg) Norethisterone 0.35mg Tablets PHARMACEUTICAL FORM
White, flat, circular, bevel-edged tablet.
CLINICAL PARTICULARSTherapeutic indications
Optinor 350 is a progestogen-only oral contraceptive. It is particularly useful for women for whom oestrogens may not be appropriate.
Posology and method of administration
Oral Administration
Starting on the first day of menstruation, one pill every day without a break in medication for as long as contraception is required. Additional contraceptive precautions (such as a condom) should be taken for the first 7 days of the first pack. Pills should be taken at the same time each day.
Missed Pills
If a pill is missed within 3 hours of the correct dosage time then the missed pill should be taken as soon as possible; this will ensure that contraceptive protection is maintained. If a pill is taken 3 or more hours late it is recommended that the woman takes the last missed pill as soon as possible and then continues to take the rest of the pills in the normal manner. However, to provide continued contraceptive protection it is recommended that an alternative method of contraception, such as a condom, is used for the next 7 days.
Changing from another oral contraceptive
In order to ensure that contraception is maintained it is advised that the first pill is taken on the day immediately after the patient has finished the previous pack.
Use after childbirth, miscarriage or abortion
The first pill should be taken on the 21st day after childbirth. This will ensure the patient is protected immediately. If there is any delay in taking the first pill, contraception may not be established until 7 days after the first pill has been taken. In these circumstances women should be advised that extra contraceptive methods will be necessary.
After a miscarriage or abortion patients can take the first pill on the next day; in this way they will be protected immediately.
Vomiting and diarrhoea
Gastrointestinal upsets, such as vomiting and diarrhoea, may interfere with the absorption of the pill leading to a reduction in contraceptive efficacy. Women should continue to take Optinor 350, but they should also be advised to use another contraceptive method during the period of gastrointestinal upset and for the next 7 days.
Contraindications
The contraindications for progestogen-only oral contraceptives are
known, suspected, or a past history of breast, genital or hormone dependent cancer; acute or severe chronic liver diseases including past or present liver tumours, Dubin-Johnson or Rotor syndrome; active liver disease; history during pregnancy of idiopathic jaundice or severe pruritus; disorders of lipid metabolism; undiagnosed abnormal vaginal bleeding ; known or suspected pregnancy; hypersensitivity to any component.Pregnancy and lactation
Optinor 350 is contraindicated in women with suspected pregnancy. Several reports suggest an association between foetal exposure to female sex hormones, including oral contraceptives, and congenital anomalies.
There is no evidence that Optinor 350 tablets diminish the yield of breast milk. Small amounts of steroid materials appear in the milk; their effect on the breast-fed child has not been determined.
Overdose
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may be manifested by nausea, vomiting, breast enlargement and vaginal bleeding. There is no specific antidote and treatment should be symptomatic. Gastric lavage may be employed if the overdose is large and the patient is seen sufficiently early (within four hours).
PHARMACOLOGICAL PROPERTIESPharmacodynamic properties
Norethisterone administration increases the protein and sialic acid content of cervical mucus which prevents penetration of the mucus by spermatozoa. It causes changes in the structure of the endometrium such that implantation of blastocysts is impaired. It also reduces numbers and height of cilia on cells lining the fallopian tube, which could delay tubal transport of ova.
PHARMACEUTICAL PARTICULARSList of excipients
Maize starch, polyvidone, magnesium stearate and lactose. Shelf life
5 years
Special precautions for storage
Store in a cool, dry place away from direct sunlight.
Nature and contents of container
Optinor 350 tablets are supplied in pvc/foil blister packs of 28 and 84 tablets. Blister packaging consists of 250 micron PVC and 20 micron aluminium foil.
TOPProstoford 125™ (Carboprost tromethamine Inj. 125 mcg) Carboprost tromethamine Inj. TOPProstoford™ (Carboprost tromethamine Inj. 250 mcg) Carboprost tromethamine Inj. Each 1 ml contains carboprost tromethamine equivalent to carboprost 125 micrograms.
Each 1 ml contains carboprost tromethamine equivalent to carboprost 250 micrograms.
PHARMACEUTICAL FORM
Colourless, sterile, aqueous solution for intramuscular injection.
CLINICAL PARTICULARS
Therapeutic indications
Treatment of post-partum haemorrhage due to uterine atony and refractory to conventional methods of treatment with oxytocic agents and ergometrine used either alone or in combination.
Posology and method of administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
An initial dose of 250 micrograms (1.0 ml) of Hemabate should be administered as a deep intramuscular injection.
If necessary, further doses of 250 micrograms may be administered at intervals of approximately 1.5 hours. In severe cases the interval between doses may be reduced at the discretion of the attending physician, but it should not be less than 15 minutes. The total dose of Hemabate should not exceed 2 mg (8 doses).
Elderly
Not applicable
Children
Not applicable.
Contraindications
Hemabate should not be used where the patient is sensitive to carboprost tromethamine or any of the excipients.
Hemabate is not recommended in the following circumstances
Acute pelvic inflammatory disease. Patients with known cardiac, pulmonary, renal or hepatic disease.Pregnancy and lactation
Hemabate is contra-indicated in pregnancy. In the unlikely event of a mother breastfeeding her baby whilst receiving Hemabate, no adverse effects to the nursing infant would be anticipated.
Overdose
Treatment of overdosage must be symptomatic at this time, as clinical studies with prostaglandin antagonists have not progressed to the point where recommendations may be made.
If evidence of excessive side-effects appears, the frequency of administration should be decreased or administration discontinued.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Carboprost is a synthetic 15-methyl analogue of dinoprost (prostaglandin F2 alpha). It is a uterine stimulant with a more prolonged action than dinoprost and when used in post-partum haemorrhage, it stimulates the uterus to contract in a manner similar to that normally observed in the uterus following delivery. The resulting myometrial contractions provide haemostasis at the site of placentation and hence prevent further blood loss. Whether or not this action results from a direct effect on the myometrium has not been determined with certainty at this time. The fundamental actions of the prostaglandins include inhibition or stimulation of smooth muscle contraction and inhibition of the release of noradrenaline or modulation of its effects at neuroeffector sites. They affect the uterus, the cardiovascular system, the gastro-intestinal system, the nervous system, the urinary system and metabolic processes.
PHARMACEUTICAL PARTICULARS
List of excipients
Benzyl alcohol, Sodium chloride, Tromethamine, Sodium hydroxide, Hydrochloric acid, Water for injections
Shelf life
Ampoules: 48 months
Vial: 24 months
Special precautions for storage
The ampoules must be stored in a refrigerator at 2 - 8°C.
The vial must be stored in a refrigerator at 0 - 6°C
Nature and contents of container
Ampoule: Type 1 glass ampoule containing 1 ml solution, packed in cartons of two or ten ampoules.
Vial: Type 1 glass with butyl rubber closure, containing 10 ml solution, packed individually in a carton.