Atenolol-AFT atenolol 50 mg/10 mL oral solution bottle

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

atenolol, Quantity: 5 mg/mL

Доступно од:

AFT Pharmaceuticals Pty Ltd

INN (Међународно име):

Atenolol

Фармацеутски облик:

Oral Liquid, solution

Састав:

Excipient Ingredients: propylene glycol; propyl hydroxybenzoate; saccharin sodium; purified water; citric acid monohydrate; sorbitol solution (70 per cent) (non-crystallising); sodium citrate dihydrate; methyl hydroxybenzoate; Flavour

Пут администрације:

Oral

Јединице у пакету:

300 mL

Класа:

Medicine Registered

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

All grades of hypertension including hypertension of renal origin.,Frequent disabling angina without evidence of cardiac failure,Cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias including those with acute myocardial infarction),Myocardial infarction - late intervention (beta-blocker class effect greater than 12 hours after onset of chest pain)

Резиме производа:

Visual Identification: Clear colourless slightly viscous liquid with lemon-lime flavour; Container Type: Bottle; Container Material: Plastic; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Статус ауторизације:

Licence status A

Датум одобрења:

2012-08-03

Информативни летак

Atenolol-AFT
Atenolol 50 mg/10 mL, Oral solution
What is in this leaflet
This leaflet answers some common questions about Atenolol-AFT. It does
not
contain all the available information. It does not take the place of
talking to your
doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the
risks of you
taking Atenolol-AFT against the benefits they expect it will have for
you.
If you have any concerns about taking this medicine, ask your doctor
or
pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Atenolol-AFT is used for
Atenolol belongs to a group of medicines called beta-blockers. It
makes the heart
beat slower and less forcefully reducing the amount of oxygen required
by the heart
and the volume of blood it has to pump. This results in lower blood
pressure. It
widens the blood vessels in the body, causing blood pressure to fall.
It helps the
heart to beat more regularly.
Atenolol-AFT is used to:
•
lower high blood pressure (hypertension)
•
prevent angina
•
treat irregular heart rhythm or beat (arrhythmias)
•
treat heart attacks, or reduce the risk of heart complications
following a heart
attack
Atenolol-AFT may be used alone or in combination with other medicines
to treat your
condition.
Atenolol-AFT may also be used in emergency situations or during
surgery to treat a
fast heart beat before, during or after surgery.
Hypertension:
Everybody has blood pressure. Blood pressure helps to move the blood
around your
body. Your blood pressure will change during the day, depending on how
busy you
are or how you are feeling.
You have hypertension (high blood pressure) when your blood pressure
stays higher
than is needed, even when you are calm and relaxed. Regular blood
pressure
checks are the only way to know if you have hypertension. There are
usually no
symptoms with hypertension and you may feel fine. If hypertension is
not treated,
serious health problems e.g. stroke, heart disease and kidney failure
may occur.
Atenolol-AFT helps to lower you

Карактеристике производа

Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
ATENOLOL-AFT (ATENOLOL) ORAL SOLUTION
1.
NAME OF THE MEDICINE
Atenolol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atenolol-AFT, oral solution, contains 50 mg atenolol per 10 mL of the
solution.
Atenolol is a white or to almost white crystalline powder which is
sparingly soluble in water, soluble in
ethanol and slightly soluble in methylene chloride. The pKa for
atenolol is 9.6. Atenolol-AFT, oral
solution also contains sorbitol solution (70 per cent)
(non-crystallising), methyl hydroxybenzoate,
propyl hydroxybenzoate, sodium saccharin, citric acid monohydrate,
sodium citrate, propylene glycol
and lemon lime flavour PHL0132956 (Proprietary Ingredient 11570).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Atenolol-AFT, oral solution is a clear, colourless, slightly viscous
liquid with a lemon-lime odour and
flavour which contains 50 mg Atenolol per 10 mL of solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
All grades of hypertension, including hypertension of renal origin.
•
Frequent disabling angina without evidence of cardiac failure.
•
Cardiac arrhythmias (acute treatment of supraventricular and
ventricular arrhythmias including
those associated with acute myocardial infarction).
•
Myocardial infarction - Late intervention (β-blocker class effect
greater than 12 hours after
onset of chest pain)
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
While literature suggests that atenolol as an oral liquid behaves in
the same way as atenolol tablets, no
data directly comparing the bioavailability of Atenolol-AFT with
atenolol tablets is available. Dose
titration should be undertaken in a controlled manner and patients
changing from the tablets to the oral
liquid (or vice versa) should be monitored with the dosage being
adjusted as appropriate.
Page 2 of 14
Given the possibility of more calibrated dose titration with an oral
solution, it may be appropriate to
initiate doses at less than 50 mg. However, this would require an
individua