Arlette 28 indications
Oral contraception.
Arlette 28, like all hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Uses of Arlette 28 in details
Arlette 28 is a type of progestetrone used to prevent pregnancy especially in women not able to tolerate estrogens or are breast feeding.
Arlette 28 description
Each film-coated tablet also contains the following excipients: Lactose <65 mg. Tablet Core: Anhydrous colloidal silica, all-rac-α-tocopherol, lactose monohydrate, maize starch, povidone, stearic acid. Film Coat: Hypromellose, macrogol 400, talc, titanium dioxide (E171).
Arlette 28 dosage
The Arlette 28 pack contains 28 tablets. Arrows are printed on the front side of the pack, between the tablets. At the back side of the pack, the days of the week are printed on the foil. Each day corresponds to 1 tablet.
Taking Arlette 28: When starting a new pack of Arlette 28, the woman should take a tablet from the top row. She should not start with just any tablet. For example, if starting on a Wednesday, she must take the tablet from the top row marked (at the back) with "WED". She should continue to take one tablet a day until the pack is empty, always following the direction indicated by the arrows. By looking at the back of the pack, she can easily check if she has already taken the tablet for a particular day.
If bleeding occurs during the use of Arlette 28, continue to take the tablets as usual. When a pack is empty, the patient should start with a new pack on the next day, thus without interruption and without waiting for a bleed.
Starting on the First Pack of Arlette 28: No Preceding Hormonal Contraceptive Used in the Past Month: The first Arlette 28 tablet should be taken on the first day of the woman's period. There is no need to take extra contraceptive precautions.
The woman can also start on days 2 to 5 of her period, but in that case, must make sure to use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking.
Switching from a Combined Pill, Vaginal Ring or Transdermal Patch: Arlette 28 can be started on the day after taking the last tablet from the woman's present pill pack, or on the day of removal of vaginal ring or patch (this means no tablet-, ring- or patch-free break). If her present pill pack also contains inactive tablets, she can start Arlette 28 on the day after taking the last active tablet (if she is not sure when this is, she should ask the physician or pharmacist). If she follows these instructions, she need not use an additional contraceptive method.
At the latest, the woman can start the day following the tablet-, ring-, patch-free break or placebo tablet interval of her present contraceptive. If she follows these instructions, an additional contraceptive method (barrier method) for the first 7 days of tablet-taking during the first cycle is necessary.
Switching from Another Progestogen-Only Pill (Mini-Pill): The woman may stop taking the mini-pill any day and start with Arlette 28 right away. Extra contraceptive precautions are not necessary.
Switching from an Injectable or Implant or a Progestogen-Releasing Intrauterine Device (IUD): Arlette 28 should be started when the next injection is due or on the day that the implant or IUD is removed. Extra contraceptive precautions are not necessary.
Following Delivery: The woman can start Arlette 28 between 21 to 28 days after the birth of the baby. If she decides to start later, an additional contraceptive method (barrier method) during the first cycle for the first 7 days of tablet-taking is necessary. However, if intercourse has already occurred, pregnancy should be excluded before starting Arlette 28 use. Additional information for breast-feeding women can be found in Use in Pregnancy & Lactation. The physician can also advise the patient.
Following a Miscarriage or Abortion: Consult the physician.
Management of Missed Tablets: If the woman is less than 12 hours late in taking a tablet, the reliability of Arlette 28 is maintained. The missed tablet should be taken as soon as she remembers and the next tablets should be taken at the usual times.
If the woman is more than 12 hours late in taking a tablet, the reliability of Arlette 28 may be reduced. The more consecutive tablets missed, the higher the risk that the contraceptive efficacy is decreased. The last missed tablet should be taken as soon as she remembers and the next tablets should be taken at the usual times. An additional contraceptive method (barrier method) should be used for the next 7 days of tablet-taking.
If one or more tablets are missed in the 1st week of tablet-intake and the woman had intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. Consult the physician for advice.
Advice in Case of Gastrointestinal Disturbances (e.g., Vomiting, Severe Diarrhea): Follow the advise in the previous text if vomiting within 3-4 hours after taking Arlette 28 occurs, or if the woman has severe diarrhoea, Arlette 28 may not have been completely absorbed.
Stopping Arlette 28 Therapy: The woman can stop taking Arlette 28 at any time. She is no longer protected against pregnancy once medication is discontinued.
Administration: The tablets should be taken at about the same time each day. The tablet should be swallowed whole with water. She may have some bleeding during the use of Arlette 28, but she must continue to take the tablets as normal. When a pack is empty, she must start with a new pack of Arlette 28 on the next day-thus without interruption and without waiting for a bleed.
Arlette 28 interactions
Interactions between OCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. The following interactions have been reported in the literature (mainly with combined contraceptives but occasionally also with POCs).
Hepatic Metabolism: Interactions can occur with medicinal products that induce microsomal enzymes, which can result in increased clearance of sex hormones [eg, hydantoins (eg, phenytoin), barbiturates (eg, phenobarbital), primidone, carbamazepine, rifampicin; and possibly also oxcarbazepine, rifabutin, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin and products containing St. John's wort (Hypericum perforatum)].
Women on treatment with any of these drugs should temporarily use a barrier method in addition to Arlette 28 or choose another method of contraception. The barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation. For women on long-term therapy with hepatic enzyme inducers, a non-hormonal method of contraception should be considered.
During treatment with medical charcoal, the absorption of the steroid in the tablet may be reduced and thereby the contraceptive efficacy. In such an event, the advice concerning missed tablets as given in Management of Missed Pills under Dosage & Administration is applicable.
Hormonal contraceptives may interfere with the metabolism of other drugs. Accordingly, plasma and tissue concentrations may either increase (eg, cyclosporine) or decrease.
Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.
Laboratory Tests: Data obtained with COCs have shown that contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, serum levels of (carrier) proteins eg, corticosteroid-binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. The changes generally remain within the normal range. To what extent this also applies to progestogen-only contraceptives is not known.
Incompatibilities: Not applicable.
Arlette 28 side effects
The most commonly reported adverse effects in the clinical trials with Arlette 28 (>2.5%) were bleeding irregularities, acne, mood changes, breast pain, nausea and weight increase. The undesirable effects mentioned as follows have been judged by the investigators as having an established, probable or possible link to the treatment.
Infections and Infestations: Uncommon (<1/100, ≥1/1000): Vaginal infection.
Psychiatric Disorders: Common (≥1/100): Altered mood, decreased libido.
Nervous System Disorders: Common: Headache.
Eye Disorders: Uncommon: Contact lens intolerance.
Gastrointestinal Disorders: Common: Nausea. Uncommon: Vomiting.
Skin and Subcutaneous Tissue Disorders: Common: Acne. Uncommon: Alopecia. Rare (<1/1000): Rash, urticaria, erythema nodosum.
Reproductive System and Breast Disorders: Common: Breast pain, irregular menstruation, amenorrhea. Uncommon: Dysmenorrhea, ovarian cyst.
General Disorders and Administration Site Condition: Uncommon: Fatigue.
Investigations: Common: Increased weight.
Breast discharge and on rare occasions, ectopic pregnancies have been reported with the use of Arlette 28 during post-marketing surveillance.
In women using COCs, a number of (serious) adverse effects have been reported. These include venous thromboembolic disorders, arterial thromboembolic disorders, hormone dependent tumors (eg, breast cancer) and chloasma, some of which are discussed in more detail in Precautions.
Arlette 28 contraindications
Progestogen-only contraceptives should not be used in the presence of any of the conditions listed as follows. Should any of the conditions appear for the first time during the use of Arlette 28, the product should be stopped immediately.
Hypersensitivity to Arlette 28 or to any of the excipients of Arlette 28.
Known or suspected pregnancy.
Active venous thromboembolic disorder.
Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
Known or suspected sex steroid-sensitive malignancies.
Undiagnosed vaginal bleeding.
Active ingredient matches for Arlette 28:
| Unit description / dosage (Manufacturer) | Price, USD |
| Tablet, Film-Coated; Oral; Desogestrel 0.075 mg | |
List of Arlette 28 substitutes (brand and generic names): | |
| Arlette-28 (Peru) | |
| Azalia (Czech Republic, Estonia, Latvia, Lithuania, Poland, Slovakia) | |
| Azalia 0.075mg (Switzerland) | |
| Azalia 75 µg (Hungary) | |
| Babette AL (Germany) | |
| Bredicon (Bangladesh) | |
| Camelia (Argentina) | |
| Carmin (Argentina) | |
| CARMIN P- oral drops 15ml (Impact) | |
| Celea (Belgium) | |
| Celea 75mcg (Luxembourg) | |
| Cerazet (Italy, Spain) | |
| Cerazette (Argentina, Austria, Bahrain, Belgium, Brazil, Chile, Colombia, Costa Rica, Croatia (Hrvatska), Czech Republic, Denmark, Dominican Republic, El Salvador, Estonia, Finland, France, Germany, Guatemala, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, Sweden, Switzerland, United Kingdom, Venezuela) | |
| Tablet, Film-Coated; Oral; Desogestrel 0.075 mg (MSD) | |
| Cerazette 75 mcg x 1 x 28's (MSD) | |
| Cerazette 75 mcg x 28's (MSD) | $ 9.88 |
| 75 mcg x 28's (MSD) | $ 2.86 |
| Cerazette 75mcg TAB / 28 (MSD) | $ 2.86 |
| CERAZETTE 0.075 MG TABLET 1 strip / 28 tablets each (MSD) | $ 4.76 |
| Cerazette tab 75 mcg 28's (MSD) | |
| Cerazette FC tab 75 mcg 28's (MSD) | |
| CERAZETTE tab 75 mcg x 28's (MSD) | $ 3.70 |
| Cerazette film-coated tab 75 mcg 28's (MSD) | $ 12.35 |
| Cerazette 0.075mg Tablet (MSD) | $ 0.17 |
| Cerazette 0.075 mg (Hungary, Oman) | |
| Cerazette 75 Mikrogramm (Germany) | |
| Cerazette 75 µg (Austria) | |
| Cerazette 適意避 (Hongkong) | |
| Cerazette film-coated tab 75 mcg 28's (Bayer) | |
| Cerelle (United Kingdom) | |
| Cevanel (Switzerland) | |
| Chalant HEXAL (Germany) | |
| Clareal (France) | |
| Cycle ratiopharm (Austria) | |
| Cycle ratiopharm 75 µg (Austria) | |
| Cyprella (Austria) | |
| Cyprella STADA (Germany) | |
| Daisenette (Czech Republic) | |
| Daisenette Neo (Czech Republic) | |
| Damara (Germany) | |
| Damara 75 Mikrogramm (Germany) | |
| Delamonie (Denmark, Lithuania, Netherlands, Sweden) | |
| Desandrelle (Poland) | |
| Desirett (Austria, Estonia, Germany, Latvia, Lithuania, Poland, Slovakia) | |
| DESIRETT 75 Mikrogramm (Germany) | |
See 174 substitutes for Arlette 28 | |
References
- DailyMed. "DESOGESTREL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "DESOGESTREL". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "DESOGESTREL". http://www.drugbank.ca/drugs/DB00304 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Arlette 28 are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Arlette 28. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
