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Cyclogest ®
Progesterone.

1.         Trade Name of the Medicinal Product
             CYCLOGEST

2.         Qualitative and Quantitative
            Composition

            Each pessary contains either 200mg  or 400mg of the active             ingredient progesterone.

 

3. Pharmaceutical Form
  Off-white pessaries
4.1 Indication and Dosage
  Threatened Abortion: Starting dose 800mg rectally, followed by 400mg every 12 hours, till
bleeding stops
Habitual Abortion: 400mg twice daily vaginally for three months.
Luteal Phase Support: 400mg twice daily vaginally or rectally.
Pre-Menstrual Syndrome: Start on day 14 of cycle with 200mg daily to  400mg twice a day,  vaginally or rectally, continue until     menstruation. If symptoms present at ovulation, start by day 12.
Post Natal Depression:200mg daily to 400mg twice a day rectally, till menses occur.
Preterm Labour: 200mg daily vaginally or rectally for 4 weeks.  
Children: Not applicable
Elderly: Not applicable.

Method of Administration:
For rectal or vaginal insertion.
4.2. Contraindications
  Carcinoma of the breast or genital organs, known or suspected
Liver dysfunction or disease
Thrombophlebitis, thromboembolic disorders, cerebral apoplexy, or past history of these disorders.
Known allergy to any of the excipients
Undiagnosed uterine bleeding
Porphyria.
4.3. Special Warnings and Precautions for Use.
 
Use rectally if barrier methods of contraception are used. Use vaginally if patients suffer from colitis or faecal Incontinence. Use rectally if suffer from vaginal infection (especially moniliasis) or recurrent cystitis. Use patients who have recently given birth. Progesterone is metabolized in the liver and should be used with caution in patients with hepatic dysfunction.
Cyclogest contains the hormone progesterone which is present in significant concentrations in women during the second half of the menstrual cycle and during pregnancy. This should be borne in mind when treating patients with conditions that may be hormone-sensitive.
4.4. Interactions with other Medicaments and otherforms of Interaction
  None known
4.5.  Pregnancy and Lactation
  As progesterone is a natural hormone, it is not expected to have adverse effects; however, no evidence is available to this effect.
4.6. Effects on Ability to Drive and Use Machines
  None known.
4.7. Undesirable Effects
 
Menstruation may occur earlier than expected, or, more rarely, menstruation may be delayed. Soreness, diarrhoea and flatulence  may occur with rectal administration. As with other vaginal and rectal preparations, some leakage of the pessary base may occur.
4.8. Overdose
 
There is a wide margin of safety with Cyclogest pessaries, but over dosage may produce euphoria or dysmenorrhea. Symptomatic  treatment recommended.
5.1. Pharmacodynamic properties
  Progesterone is a progestational steroid
5.2. Pharmacokinetic properties
 
Rectal or vaginal administration of 100-400mg produces concentrations in the luteal range which are maximal within 1-8 hours and then decline over 24 hours. The half life of progesterone in the blood is short. It has been estimated that progesterone  has a distribution half life of between 3-6 minutes followed by an elimination half life of 19­-95 minutes.The metabolic clearance rate  is between 1800 & 2500 litres daily and the apparent volume of distribution is 17-29 litres. Circulating progesterone is extensively bound to plasma proteins, especially albumin and corticosteroid binding globulin.
Progesterone undergoes extensive   biotransformation mainly in the liver(66%) and in tissues
such as kidneys, brains, uterus and skin.
The metabolites of progesterone are conjugated in the liver with glucoronic acid and excreted in the urine or faeces. There is extensive enterohepatic recirculation of progesterone metabolites.
5.3. Preclinical safety data
  Not applicable.
6.1. List of excipients
  Also contains: vegetable fat.
6.2. Incompatibilities
  None known
6.3. Shelf-life
  Thirty six months
6.4. Special precautions for storage
  Store below 25°C in a dry place Preferably between 2 - 8°C.
6.5. Nature and contents of container
  Thermoplastic film strips
Pack size: 15
6.6. Instructions for use/handling
  Not applicable.
7. Marketing Authorization Holder
  Actavis, Barnstaple,
EX32 8NS, UK
8. Date of Last Revision
  September 2003
 
Sole Agent & Distributor:
Excel Healthcare Laboratories (Pvt) Ltd. D-122, Block-4 Federal “B” Area. Karachi-Pakistan

 

 
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