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Naphanor

Naphanor

COMPOSITIONS:
Each tablet contains Levonorgestrel 0.75 mg. Excipients q.s 1 tablet.


PHARMACEUTICAL DOSAGE FORM:
tablet.

PHARMACODYNAMICS:

It is a kind of short term and instant released contraceptive. It significantly restrains ovulation and disturbs theembedment. It increases the thickness of the cervix muscus and  sperm penetrating resistance, thus exerts the instant action of contraception.


PHARMACOKINETICS:


Absorption:

No specific  investigation  of  the  absolute  bioavailability  of  Naphanor  in humans  has  been conducted.  However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first pass metabolism. After a single dose of Naphanor (0.75 mg) administered to 16 women under fasting conditions, maximum serum concentrations of levonorgestrel are 14.1 + 7.7 ng/mL (mean + SD) at an average of  1.6  +  0.7  hours. No  formal  study  of  the  effect  of  food  on  the  absorption  of levonorgestrel has been undertaken.

Table 1.  Pharmacokinetic Parameter Values Following Single Dose Administration of Naphanor

(Levonorgestrel) Tablets 0.75 mg to Healthy Female Volunteers

N

Mean (+ S.D.)

Cmax

(ng/mL)

Tmax

(h)

CL

(L/h)

Vd

(L)

T½

(h)

AUC0-∞

(ng/mL/h)

16

14.1 + 7.7

1.6 + 0.7

7.7 + 2.7

260.0

24.4 + 5.3

123.1 + 50.1




INDICATIONS

NAPHANOR is a formulation for emergency contraception, can prevent pregnancy within 72 hours after unprotected intercourse. NAPHANOR- Emergency contraceptive pills is used in the following cases:

  • Having not using any contraceptive method during intercourse.
  • Or contraceptive methods used are not reliable:

- The condom broke, slipped or misused.

- Diaphragm or vaginal contraceptive pills was misplaced, torn or removed too soon.

-  intercourse is interrupted and failed.

- Miscalculation of ovulation with history method.

- IUD is removed or lost

- Forget using daily birth control pills over three days.

  • Being raped

CONTRAINDICATIONS

Pregnancy or suspected pregnancy, vaginal bleeding of unknown cause, having liver and kidneys troubles, jaundice during pregnancy, having family history of breast, ovary and uterus cancer.

DOSAGE AND ADMINISTRATION:

- Take one Naphanor tablet as soon as possible right after intercourse without reliable birth control or contraceptive method. Ideally used within 48 hours and not exceeds 72 hours.

- Take the second Naphanor tablet after the first tablet around 12 hours (not later than 16 hours)

- If you vomit within 2 hours after taking the first tablet , you need to take an other tablet.

- If you vomit within 2 hours after taking the second tablet,  you need to take another, or consult the doctor / pharmacist immediately.

 

SIDE EFFECTS

Naphanor may cause nausea, vomiting, abdominal pain, fatigue, headache, menstrual changes. If bleeding occurrs after 2 -3 days , stop taking. In most cases, a new menstrual period begins as expected or earlier. If the menstrual period is delayed more than 7 day, you should take a pregnancy test. If bleeding is persistent, pelvic examination is recommended


DRUG INTERACTIONS

Theoretically, the effectiveness of low-dose progestin-only pills is reduced by hepatic enzyme- inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and barbiturates, and theantituberculosis drug rifampin. No significant interaction has been found with broad-spectrum antibiotics.  It is not known whether the efficacy of Naphanor would be affected by these or any other medications.

ADVERSE REACTIONS

The most common adverse events in the clinical trial for women receiving Naphanor included nausea and vomiting, abdominal pain, fatigue, headache, and menstrual changes.

If the symptoms are serious, please consult doctors.

OVERDOSAGE

There are no data on overdosage of Naphanor, although the common adverse event of nausea and its associated vomiting may be anticipated.

PACKING SIZE: Box of 1 blister of 2 tablets.

STORAGE: store in a cool and dry place, protect from light, at room temperature (150C – 300C).

SHELF-LIFE: 5 years.

SPECIFICATION: BP 2010

Manufacturer:

Nam Ha Pharmaceutical Joint-Stock Company

No.415 Han Thuyen Street, Nam Dinh City, Nam Dinh Province, Viet Nam.

Prodcuts

Namha Pharmaceutical joint-stock company

Trade name: Namha Pharma

Head office: 415 Han Thuyen – Nam Dinh – Vietnam

Tel:  84-0350-3649408      Fax: 84-0350-644650

Copyright © 2010 NamHa Pharmaceutical Joint Stock Company, All rights reserved.