Samba Uses

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What is Samba?

Samba combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, Samba, and when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

Samba does not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

Samba is available only with your doctor's prescription.

Samba indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Samba Tablets, USP and Ethinyl Estradiol Tablets, USP are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.

TABLE II: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR, UNITED STATES.

†Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.

‡Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.

* Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.

§ The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.

¶ Foams, creams, gels, vaginal suppositories, and vaginal film.

# Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.

Þ With spermicidal cream or jelly.

ß Without spermicides.

% of Women Experiencing an Unintended

Pregnancy within the First Year of Use

% of Women

Continuing Use at

One Year*

Method

(1)

Typical Use†

(2)

Perfect Use‡

(3)

(4)

Chance§

85

85

Spermicides¶

26

6

40

Periodic abstinence

25

63

Calendar

9

Ovulation Method

3

Sympto-Thermal#

2

Post-Ovulation

1

Withdrawal

19

4

CapÞ

Parous Women

40

26

42

Nulliparous Women

20

9

56

Sponge

Parous Women

40

20

42

Nulliparous Women

20

9

56

DiaphragmÞ

20

6

56

Condomß

Female (Reality)

21

5

56

Male

14

3

61

Pill

5

71

Progestin Only

0.5

Combined

0.1

IUD

Progesterone T

2.0

1.5

81

Copper T 380A

0.8

0.6

78

LNg 20

0.1

0.1

81

Depo-Provera

0.3

0.3

70

Norplant and Norplant-2

0.05

0.05

88

Female sterilization

0.5

0.5

100

Male sterilization

0.15

0.10

100

Adapted from Hatcher et al., 1998, Ref#1.

Samba description

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Each pack of Samba consists of 21 tablets: Each tablet contains Desogestrel (Samba) (a progestogen) 150 mcg and Ethinylestradiol (Samba) (an estrogen) 20 mcg.

Samba dosage

Taking Samba: Samba tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval, during which time a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started.

Administration: No Preceding Hormonal Contraceptive Use (In The Past Month): Tablet-taking has to start on day 1 of the woman's natural cycle (ie, the 1st day of her menstrual bleeding). Starting on days 2-5 is allowed, but during the 1st cycle a barrier method is recommended in addition for the 1st 7 days of tablet-taking.

If menstruation began >5 days previously then the patient should be advised to wait until her next menstrual period before starting to take Samba.

Changing From A Combined Hormonal Contraceptive [Combined

Oral Contraceptive (COC), Vaginal Ring, or Transdermal Patch]: The woman should start with Samba preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC. In case a vaginal ring or transdermal patch has been used, the woman should start using Samba preferably on the day of removal, but at the latest when the next application would have been due.

If the woman has been using her previous method consistently and correctly and if it is reasonably certain that she is not pregnant she may also switch from her previous combined hormonal contraceptive on any day of the cycle.

The hormone-free interval of the previous method should never be extended beyond its recommended length.

Changing From A Progestogen-only-method (Minipill, Injection, Implant) or From A Progestogen-releasing intrauterine system (IUS): The woman may switch any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due), but should in all of these cases be advised to additionally use a barrier method for the 1st 7 days of tablet-taking.

Following 1st-trimester Abortion: The woman may start immediately. When doing so, she need not take additional contraceptive measures.

Following Delivery or 2nd-trimester Abortion: For breastfeeding women see Use in Pregnancy and Use in lactation under Contraindications.

Women should be advised to start at day 21-28 after delivery or 2nd trimester abortion.

When starting later, the woman should be advised to additionally use a barrier method for the 1st 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of COC use or the woman has to wait for her 1st menstrual period.

Management of Missed Tablets: If the user is <12 hrs late in taking any tablet, contraceptive protection is not reduced.

The woman should take the tablet as soon as she remembers and should take further tablets at the usual time.

If the user is >12 hrs late in taking any tablet, contraceptive protection may be reduced.

The management of missed tablets can be guided by the following 2 basic rules: Tablet-taking must never be discontinued for >7 days.; 7 days of uninterrupted tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis.

Accordingly, the following advice can be given in daily practice: Week 1: The user should take the last missed tablet as soon as she remembers, even if this means taking 2 tablets at the same time. She then continues to take tablets at her usual time. In addition, a barrier method eg, a condom should be used for the next 7 days. If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered. The more tablets are missed and the closer they are to the regular tablet-free interval, the higher the risk of a pregnancy.

Week 2: The user should take the last missed tablet as soon as she remembers, even if this means taking 2 tablets at the same time. She then continues to take tablets at her usual time. Provided that the woman has taken her tablets correctly in the 7 days preceding the 1st missed tablet, there is no need to use extra contraceptive precautions. However, if this is not the case, or if she missed >1 tablet, the woman should be advised to use extra precautions for 7 days.

Week 3: The risk of reduced reliability is imminent because of the forthcoming tablet-free interval. However, by adjusting the tablet-intake schedule, reduced contraceptive protection can still be prevented.

By adhering to either of the following 2 options, there is therefore no need to use extra contraceptive precautions, provided that in the 7 days preceding the 1st missed tablet the woman has taken all tablets correctly. If this is not the case, the woman should be advised to follow the 1st of these 2 options and to use extra precautions for the next 7 days as well.

The user should take the last missed tablet as soon as she remembers, even if this means taking 2 tablets at the same time. She then continues to take tablets at her usual time. The next pack must be started as soon as the current pack is finished, ie, no gap should be left between packs. The user is unlikely to have a withdrawal bleed until the end of the 2nd pack, but she may experience spotting or breakthrough bleeding on tablet-taking days.

The woman may also be advised to discontinue tablet-taking from the current pack. She should then have a tablet-free interval of up to 7 days, including the days she missed tablets, and subsequently continue with the next pack.

If the woman missed tablets and subsequently has no withdrawal bleed in the 1st normal tablet-free interval, the possibility of a pregnancy should be considered.

Advice In Case Of Gastrointestinal Disturbances: In case of severe gastrointestinal disturbance, absorption may not be complete and additional contraceptive measures should be taken.

If vomiting occurs within 3-4 hrs after tablet-taking, the advice concerning missed tablets is applicable. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) needed from another pack.

How To Shift Periods or How To Delay A Period: To delay a period the woman should continue with another pack of Samba without a tablet-free interval. The extension can be carried on for as long as wished until the end of the 2nd pack.

During the extension the woman may experience breakthrough bleeding or spotting. Regular intake of Samba is then resumed after the usual 7-day tablet-free interval.

To shift her period to another day of the week than the woman is used to with her current scheme, she can be advised to shorten her forthcoming tablet-free interval by as many days as she likes.

The shorter the interval, the higher the risk that she does not have a withdrawal bleed and will experience breakthrough bleeding and spotting during the 2nd pack (just as when delaying a period).

Samba interactions

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Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or oral contraceptive failure. The following interactions have been reported in the literature.

Hepatic Metabolism: Interactions can occur with drugs that induce microsomal enzymes, which can result in increased clearance of sex hormones (eg, hydantoins, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and products containing St. John's wort). Maximal enzyme induction is generally not seen for 2-3 weeks but may then be sustained for at least 4 weeks after the cessation of drug therapy.

Contraceptive failures have also been reported with antibiotics eg, ampicillin and tetracyclines. The mechanism of this effect has not been elucidated.

Women on treatment with any of these drugs should temporarily use a barrier method in addition to the combined oral contraceptive (COC) or choose another method of contraception. With microsomal enzyme-inducing drugs, the barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation. In case of long-term treatment with microsomal enzyme-inducing drugs, another method of contraception should be considered. Women on treatment with antibiotics (except rifampicin and griseofulvin, which also act as microsomal enzyme-inducing drugs) should use the barrier method until 7 days after discontinuation. If the period during which the barrier method is used runs beyond the end of the tablets in the COC pack, the next COC pack should be started without the usual tablet-free interval.

Oral contraceptives may affect the metabolism of other drugs. Accordingly, plasma and tissue concentrations may either increase (eg, cyclosporin) or decrease (eg, lamotrigine).

Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.

Laboratory Tests: The use of contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins, eg, corticosteroid-binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Changes generally remain within the normal laboratory range.

Incompatibilities: Not applicable.

Samba side effects

See also:
What are the possible side effects of Samba?

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Possibly related undesirable effects that have been reported in users of Samba or combined oral contraceptive (COC) users in general are listed as follows (The most appropriate MedDRA term version 11.0 to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well): System Organ Class: Common (>1/100 ); uncommon (>1/1000 and <1/100); rare (<1/1000).

Immune System Disorders: Rare: Hypersensitivity.

Metabolism and Nutrition Disorders: Uncommon: Fluid retention.

Psychiatric Disorders: Common: Depressed and altered mood. Uncommon: Decreased libido. Rare: Increased libido.

Nervous System Disorders: Common: Headache. Uncommon: Migraine.

Eye Disorders: Rare: Contact lens intolerance.

Gastrointestinal Disorders: Common: Nausea, abdominal pain. Uncommon: Vomiting, diarrhoea.

Skin and Subcutaneous Tissue Disorders: Uncommon: Rash, urticaria. Rare: Erythema nodosum, erythema multiforme.

Reproductive System and Breast Disorders: Common: Breast pain, breast tenderness. Uncommon: Breast enlargement. Rare: Vaginal discharge, breast discharge.

Investigations: Common: Increased weight. Rare: Decreased weight.

A number of adverse effects have been reported in women using combined oral contraceptives, which are discussed in more detail in Warnings and Precautions. These include: Venous thromboembolic disorders; arterial thromboembolic disorders; hypertension; hormone-dependent tumours (eg, liver tumours, breast cancer); chloasma; cholelithiasis (gallstone formation), cholestatic jaundice.

Samba contraindications

Hypersensitivity to Samba (Samba) or to any of the excipients of Samba.

Combined oral contraceptives should not be used in the presence of any of the conditions listed as follows. Should any of the conditions appear for the 1st time during COC use, Samba should be stopped immediately.

Presence or a history of venous thrombosis (eg, deep venous thrombosis, pulmonary embolism); presence or history of arterial thrombosis (myocardial infarction, cerebrovascular accident) or prodromal conditions (eg, transient ischemic attack, angina pectoris); known predisposition for venous or arterial thrombosis eg, activated protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies; history of migraine with focal neurological symptoms; diabetes mellitus with vascular involvement.

The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication; pancreatitis or a history thereof, if associated with severe hypertriglyceridemia; presence or history of severe hepatic disease as long as liver function values have not returned to normal; cholestatic jaundice; a history of jaundice of pregnancy or jaundice due to the use of steroids; Rotor syndrome and Dubin-Johnson syndrome; presence or history of liver tumors (benign or malignant); known or suspected sex steroid-influenced malignancies (eg, of the genital organs or the breasts); undiagnosed vaginal bleeding; severe hypertension; endometrial hyperplasia; porphyria.

Use in pregnancy: Samba is not indicated during pregnancy. If pregnancy occurs during treatment with Samba, further intake should be stopped. However, most epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy nor a teratogenic effect when COCs were taken inadvertently during early pregnancy.

Use in lactation: Lactation may be influenced by COCs as they may reduce the quantity and change the composition of breast milk. Therefore, the use of COCs should generally not be recommended until the nursing mother has completely weaned the child. Small amounts of the contraceptive steroids and/or their metabolites may be excreted with the milk but there is no evidence that this adversely affects infant health.



Active ingredient matches for Samba:

Desogestrel/Ethinylestradiol in Bulgaria, Estonia, Latvia, Lithuania.

Desogestrel and ethinylestradiol in Romania.


List of Samba substitutes (brand and generic names)

Sort by popularity
Unit description / dosage (Manufacturer)Price, USD
Oilezz 22's (Organon)
Tablet; Oral; Desogestrel; Ethinyl Estradiol (Nourypharma)
Capsule; Oral; Temazepam (Menarini)
Capsules; Oral; Temazepam (Menarini)
Praline 21's
Tablet, Film-Coated; Oral; Desogestrel 0.15 mg; Ethinyl Estradiol 0.03 mg (Gedeon Richter)
Regulon - 21 Tablets (Gedeon Richter)$ 20.80
Regulon - 63 Tablets (Gedeon Richter)$ 22.90
Regulon 1 x 21's (Gedeon Richter)
Regulon 3 x 21's (Gedeon Richter)
Regulon 6 x 21's (Gedeon Richter)
Regulon 1 Blister 21 Tablet (Gedeon Richter)
Regulon 3 Blister x 21 Tablet (Gedeon Richter)
Regulon FC tab 1 x 21's (Gedeon Richter)
Regulon FC tab 3 x 21's (Gedeon Richter)
Regulon FC tab 6 x 21's (Gedeon Richter)
Tablet; Oral; Desogestrel 0.15 mg; Ethinyl Estradiol 0.03 mg (Intervet)
Tablet, Film-Coated; Oral; Desogestrel 0.15 mg; Ethinyl Estradiol 0.03 mg

References

  1. 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).
  2. PubChem. "DESOGESTREL". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "DESOGESTREL". http://www.drugbank.ca/drugs/DB00304 (accessed September 17, 2018).

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