Doxycycline-Asteria capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

doxycycline (doxycycline hyclate)

Available from:

Hankook Korus Pharm Co.

ATC code:

J01AA02

INN (International Name):

doxycycline (doxycycline hyclate)

Dosage:

100mg

Pharmaceutical form:

capsules

Units in package:

(20/2x10/) and (100/10x10/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-09-30

Patient Information leaflet

(120X190)mm
To be prescribed
ATC Code : A01AB22
COMPOSITION
_Each capsule contains:_
Doxycycline hyclate -----------100.0mg(potency)
_Excipients: _Lactose, Polyvinylpyrrollidone K30, Magnesium stearate
INDICATIONS
Infectious diseases caused by susceptible organisms, including Rocky
Mountain spotted fever, murine typhus,
recrudescent epidemic typhus, scrub typhus, Q fever, lymphogranuloma
venereum, psittacosis, tularemia, brucellosis
(in conjunction with Streptomycin).
Doxycycline may be used in the treatment of gonorrhea, syphilis and
anthrax in case where the patient is
hypersensitive to penicillin.
Doxycycline is further indicated in the treatment of Chlamydia
infections.
CONTRAINDICATIONS
Doxycycline is contra-indicated in persons who have shown sensitivity
to any of the tetracyclines.
Pregnancy and lactation.
Patients with systemic lupus erythematosus.
WARNING
- Use with care in patients with liver function impairment.
- Do not use concomitantly with hepatotoxic medicines.
- Tooth discolouration, enamel hypoplasia and retarded bone growth may
occur in children under the age of 12years.
- Symptoms of myasthenia may be aggravated.
- Pseudotumour cerebri may occur.
DOSAGE AND ADMINISTRATION
_Adults: _
_Maintenance dose:_
One capsule (100mg) per day as a single dose except in more severe
infections, where two capsules (200mg) daily
should be given throughout the treatment period.
oesophageal
irritation and ulceration.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
especially with
high doses and most are attributed to irritation of the mucosa.
Oesophageal ulceration has also been reported,
with resistant
Staphylococci causing enterocolitis, and also pseudomembranous colitis
have been reported. Doxycycline
is deposited in calcifying areas in bone, teeth and nails. When given
in therapeutic doses to young
infants or women during the late stages of pregnancy tetracyclines
interfere with bone growth. Discolouration of teeth
and enamel hypoplasia.
An increase in intracranial pressure, has been reported.
_Skin:_
Allergic reaction

Summary of Product characteristics

Summary of Product Characteristics
1.
NAME OF THE MEDICINAL
PRODUCT Doxycycline-Asteria
100mg Cap.
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION Active ingredient
No.
Chemical Name
Quantity/ Cap.
Use
1
Doxycycline
Hyclate
100.0mg(potency
)
Active
ingredient
Excipient(s)
No.
Chemical Name
Quantity/ Cap.
Use
1
Lactose
200.0m
g
Inactive
2
Polyvinylpyrrollidone
K30
17.0mg
Binder
3
Magnesium stearate
3.0mg
Lubricant
3.
PHARMACEUTICAL
FORM Hard capsule
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Infectious diseases caused by susceptible organisms, including Rocky
Mountain spotted
fever,
murine
typhus,
recrudescent
epidemic
typhus,
scrub
typhus,
Q
fever,
lymphogranuloma
venereum,
psittacosis,
tularemia,
brucellosis
(in
conjunction
with
Streptomycin).
Doxycycline may be used in the treatment of gonorrhea, syphilis and
anthrax in case
where the patient is hypersensitive to penicillin.
Doxycycline is further indicated in the treatment of Chlamydia
infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Two capsules (200mg) on the first day of treatment as a single dose or
one capsule
(100mg) every 12hours.
Maintenance dose:
One capsule (100mg) per day as a single dose except in more severe
infections, where two
capsules (200mg) daily should be given throughout the treatment
period.
Administration of adequate amounts of fluid with the capsules is
recommended to reduce
the risk of oesophageal irritation and ulceration.
4.3
CONTRAINDICATIONS
Doxycycline is contra-indicated in persons who have shown sensitivity
to any of the
tetracyclines.
Pregnancy and lactation.
Patients with systemic lupus erythematosus.
4.4
SPECIAL WARNINGS AND
PRECAUTIONS WARNINGS
-Use with care in patients with liver function impairment.
-Do not use concomitantly with hepatotoxic medicines.
-Tooth discolouration, enamel hypoplasia and retarded bone growth may
occur in children
under the age of 12years.
(These effects may also occur in the foetus if given to pregnant
women)
-Symptoms of myasthenia may be aggravated.
-Photosensitivity may occur