Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Dianette is recommended for use in women only for the treatment of (a) severe acne, refractory to prolonged oral antibiotic therapy; (b) moderately severe hirsutism. Although Dianette also acts as an oral contraceptive, it should not be used in women solely for contraception, but should be reserved for those women requiring treatment for the androgen-dependent conditions described.

Complete remission of acne is to be expected in nearly all cases, often within a few months, but in particularly severe cases treatment for longer may be necessary before the full benefit is seen. It is recommended that treatment be withdrawn 3 to 4 cycles after the indicated condition(s) has/have completely resolved and that Dianette is not continued solely to provide oral contraception. Repeat courses of Dianette may be given if the androgen-dependent condition(s) recur.

Adult Dosage

Dianette inhibits ovulation and thereby prevents conception. Patients who are using Dianette should not therefore use an additional hormonal contraceptive, as this will expose the patient to an excessive dose of hormones and is not necessary for effective contraception.

First treatment course: One tablet daily for 21 days, starting on the first day of the menstrual cycle (the first day of menstruation counting as Day 1).

Subsequent courses: Each subsequent course is started after 7 tablet-free days have followed the preceding course.

When the contraceptive action of Dianette is also to be employed, it is essential that the above instructions be rigidly adhered to. Should bleeding fail to occur during the tablet-free interval, the possibility of pregnancy must be excluded before the next pack is started.

When changing from an oral contraceptive and relying on the contraceptive action of Dianette, follow the instructions given below:

Changing from 21-day combined oral contraceptives: The first tablet of Dianette should be taken on the first day immediately after the end of the previous oral contraceptive course. Additional contraceptive precautions are not required.

Changing from a combined Every Day pill (28 day tablets):

Dianette should be started after taking the last active tablet from the Every Day Pill pack. The first Dianette tablet is taken the next day. Additional contraceptive precautions are not then required.

Changing from a progestogen-only pill (POP):

The first tablet of Dianette should be taken on the first day of bleeding, even if a POP has already been taken on that day. Additional contraceptive precautions are not then required. The remaining progestogen-only pills should be discarded.

Post-partum and post-abortum use:

After pregnancy, Dianette can be started 21 days after a vaginal delivery, provided that the patient is fully ambulant and there are no puerperal complications. Additional contraceptive precautions will be required for the first 7 days of pill taking. Since the first post-partum ovulation may precede the first bleeding, another method of contraception should be used in the interval between childbirth and the first course of tablets. Lactation is contra-indicated with Dianette. After a first-trimester abortion, Dianette may be started immediately in which case no additional contraceptive precautions are required.

Special circumstances requiring additional contraception

Incorrect administration: A single delayed tablet should be taken as soon as possible, and if this can be done within 12 hours of the correct time, contraceptive protection is maintained. With longer delays, additional contraception is needed. Only the most recently delayed tablet should be taken, earlier missed tablets being omitted, and additional non-hormonal methods of contraception (except the rhythm or temperature methods) should be used for the next 7 days, while the next 7 tablets are being taken. Additionally, therefore, if tablet(s) have been missed during the last 7 days of a pack, there should be no break before the next pack is started. In this situation, a withdrawal bleed should not be expected until the end of the second pack. Some breakthrough bleeding may occur on tablet taking days but this is not clinically significant. If the patient does not have a withdrawal bleed during the tablet-free interval following the end of the second pack, the possibility of pregnancy must be ruled out before starting the next pack.

Gastro-intestinal upset: Vomiting or diarrhoea may reduce the efficacy of oral contraceptives by preventing full absorption. Tablet-taking from the current pack should be continued. Additional non-hormonal methods of contraception (except the rhythm or temperature methods) should be used during the gastro-intestinal upset and for 7 days following the upset. If these 7 days overrun the end of a pack, the next pack should be started without a break. In this situation, a withdrawal bleed should not be expected until the end of the second pack. If the patient does not have a withdrawal bleed during the tablet-free interval following the end of the second pack, the possibility of pregnancy must be ruled out before starting the next pack. Other methods of contraception should be considered if the gastro-intestinal disorder is likely to be prolonged.

Child Dosage

Contra Indications

1. Pregnancy or lactation

2. Severe disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumours.

3. Personal or family history of confirmed, idiopathic venous thromboembolism (VTE) (where a family history refers to VTE in a sibling or parent at a relatively early age).

4. Current venous thrombotic or embolic processes.

5. Existing or previous arterial thrombotic or embolic processes.

6. The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication (see section 4.4).

7. Sickle-cell anaemia.

8. Mammary or endometrial carcinoma, or a history of these conditions.

9. Severe diabetes mellitus with vascular changes.

10. Disorders of lipid metabolism.

11. History of herpes gestationis.

12. Deterioration of otosclerosis during pregnancy.

13. Undiagnosed abnormal vaginal bleeding.

14. Hypersensitivity to any of the components of Dianette.

Special Precautions

Dianette inhibits ovulation and thereby prevents conception. Patients who are using Dianette should not therefore use an additional hormonal contraceptive, as this will expose the patient to an excessive dose of hormones and is not necessary for effective contraception.

First treatment course: One tablet daily for 21 days, starting on the first day of the menstrual cycle (the first day of menstruation counting as Day 1).

Subsequent courses: Each subsequent course is started after 7 tablet-free days have followed the preceding course.

When the contraceptive action of Dianette is also to be employed, it is essential that the above instructions be rigidly adhered to. Should bleeding fail to occur during the tablet-free interval, the possibility of pregnancy must be excluded before the next pack is started.

When changing from an oral contraceptive and relying on the contraceptive action of Dianette, follow the instructions given below:

Changing from 21-day combined oral contraceptives: The first tablet of Dianette should be taken on the first day immediately after the end of the previous oral contraceptive course. Additional contraceptive precautions are not required.

Changing from a combined Every Day pill (28 day tablets):

Dianette should be started after taking the last active tablet from the Every Day Pill pack. The first Dianette tablet is taken the next day. Additional contraceptive precautions are not then required.

Changing from a progestogen-only pill (POP):

The first tablet of Dianette should be taken on the first day of bleeding, even if a POP has already been taken on that day. Additional contraceptive precautions are not then required. The remaining progestogen-only pills should be discarded.

Post-partum and post-abortum use:

After pregnancy, Dianette can be started 21 days after a vaginal delivery, provided that the patient is fully ambulant and there are no puerperal complications. Additional contraceptive precautions will be required for the first 7 days of pill taking. Since the first post-partum ovulation may precede the first bleeding, another method of contraception should be used in the interval between childbirth and the first course of tablets. Lactation is contra-indicated with Dianette. After a first-trimester abortion, Dianette may be started immediately in which case no additional contraceptive precautions are required.

Length of use

Complete remission of acne is to be expected in nearly all cases, often within a few months, but in particularly severe cases treatment for longer may be necessary before the full benefit is seen. It is recommended that treatment be withdrawn 3 to 4 cycles after the indicated condition(s) has/have completely resolved and that Dianette is not continued solely to provide oral contraception. Repeat courses of Dianette may be given if the androgen-dependent condition(s) recur.

Special circumstances requiring additional contraception

Incorrect administration: A single delayed tablet should be taken as soon as possible, and if this can be done within 12 hours of the correct time, contraceptive protection is maintained. With longer delays, additional contraception is needed. Only the most recently delayed tablet should be taken, earlier missed tablets being omitted, and additional non-hormonal methods of contraception (except the rhythm or temperature methods) should be used for the next 7 days, while the next 7 tablets are being taken. Additionally, therefore, if tablet(s) have been missed during the last 7 days of a pack, there should be no break before the next pack is started. In this situation, a withdrawal bleed should not be expected until the end of the second pack. Some breakthrough bleeding may occur on tablet taking days but this is not clinically significant. If the patient does not have a withdrawal bleed during the tablet-free interval following the end of the second pack, the possibility of pregnancy must be ruled out before starting the next pack.

Gastro-intestinal upset: Vomiting or diarrhoea may reduce the efficacy of oral contraceptives by preventing full absorption. Tablet-taking from the current pack should be continued. Additional non-hormonal methods of contraception (except the rhythm or temperature methods) should be used during the gastro-intestinal upset and for 7 days following the upset. If these 7 days overrun the end of a pack, the next pack should be started without a break. In this situation, a withdrawal bleed should not be expected until the end of the second pack. If the patient does not have a withdrawal bleed during the tablet-free interval following the end of the second pack, the possibility of pregnancy must be ruled out before starting the next pack. Other methods of contraception should be considered if the gastro-intestinal disorder is likely to be prolonged.

Interactions

Hepatic enzyme inducers such as barbiturates, primidone, phenobarbitone, phenytoin, phenylbutazone, rifampicin, carbamazepine and griseofulvin can impair the contraceptive efficacy of Dianette. For women receiving long-term therapy with hepatic enzyme inducers, another method of contraception should be used. The use of antibiotics may also reduce the contraceptive efficacy of Dianette, possibly by altering the intestinal flora.

Women receiving short courses of enzyme inducers and broad spectrum antibiotics should take additional, non-hormonal (except rhythm or temperature method) contraceptive precautions during the time of concurrent medication and for 7 days afterwards. If these 7 days overrun the end of a pack, the next pack should be started without a break. In this situation, a withdrawal bleed should not be expected until the end of the second pack. If the patient does not have a withdrawal bleed during the tablet-free interval following the end of the second pack, the possibility of pregnancy must be ruled out before resuming with the next pack.

The possibility cannot be ruled out that oral tetracyclines, if used in conjunction with Dianette may reduce its contraceptive efficacy, although it has not been shown. When drugs of these classes are being taken it is, therefore, advisable to use additional non-hormonal methods of contraception (except the rhythm or temperature methods) since an extremely high degree of protection must be provided when Dianette is being taken. With rifampicin, additional contraceptive precautions should be continued for 4 weeks after treatment stops, even if only a short course was administered.

The requirement for oral antidiabetics or insulin can change as a result of the effect on glucose tolerance.

The herbal remedy St John's wort (Hypericum perforatum) should not be taken concomitantly with Dianette as this could potentially lead to a loss of contraceptive effect.

Adverse Reactions

There is an increased risk of venous thromboembolism for all women who use Dianette.

In rare cases, headaches, gastric upsets, nausea, vomiting, breast tenderness, changes in body weight, changes in libido, depressive moods can occur.

Post-marketing reports of severe depression in patients using Dianette have been received. However, a causal relationship between clinical depression and Dianette has not been established.

In predisposed women, use of Dianette can sometimes cause chloasma which is exacerbated by exposure to sunlight. Such women should avoid prolonged exposure to sunlight.

Individual cases of poor tolerance of contact lenses have been reported with use of oral contraceptives. Contact lens wearers who develop changes in lens tolerance should be assessed by an ophthalmologist.

Menstrual changes:

1. Reduction of menstrual flow:

This is not abnormal and it is to be expected in some patients. Indeed, it may be beneficial where heavy periods were previously experienced.

2. Missed menstruation:

Occasionally, withdrawal bleeding may not occur at all. If the tablets have been taken correctly, pregnancy is unlikely. Should bleeding fail to occur during the tablet-free interval the possibility of pregnancy must be excluded before the next pack is started.

Intermenstrual bleeding: "Spotting" or heavier "breakthrough bleeding" sometimes occur during tablet taking, especially in the first few cycles, and normally cease spontaneously. Dianette should therefore, be continued even if irregular bleeding occurs. If irregular bleeding is persistent, appropriate diagnostic measures to exclude an organic cause are indicated and may include curettage. This also applies in the case of spotting which occurs at regular intervals in several consecutive cycles or which occurs for the first time after long use of Dianette.

Effect on blood chemistry: The use of oral contraceptives may influence the results of certain laboratory tests including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of carrier proteins and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Laboratory staff should therefore be informed about oral contraceptive use when laboratory tests are requested.

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