FORM DA-2/88

APPLICATION FORM FOR THE REGISTRATION OF DRUGS (WHICH ARE NOT INCLUDED
AS MONOGRAPH IN BP/BPC/-NF/INT.PH. OR ARE NOT INTRODUCED IN BANGLADESH)
____________________________________________________________________________

1. NAME OF THE MANUFACTURER : Incepta Pharmaceuticals Ltd.

AND PLACE OF MANUFACTURING Savar, Dhaka.
____________________________________________________________________________
2. MANUFACTURING LICENCE NO. : a) Biological 108
b) Non-Biological 193
____________________________________________________________________________

3. NAME OF THE PREPARATION :

a) Generic Name : Phenylephrine Hydrochloride

b) Trade/Brand Name : To be submitted at the time of

inclusion
____________________________________________________________________________
PRODUCT DATA SHEET

a) Presentation and Packaging Quantities:

Each box contain 30’s tablet. Each tablet contains Phenylephrine Hydrochloride 10mg.

b) Description:
Phenylephrine is a sympathomimetic with mainly direct effects on alpha-adrenergic
receptors and weak beta-adrenergic activity. It causes vasoconstriction of the arterioles
of the nasal mucosa and conjunctiva; activates the dilator muscle of the pupil to cause
contraction; produces vasoconstriction of arterioles in the body and produces systemic
arterial vasoconstriction.
Onset: Subcutaneous/IM/Ophthalmic: 10-15 min. IV: immediate.
Duration: Subcutaneous: 1 hr; IM: Up to about 2 hr; IV: 15-30 min; Ophthalmic: maximal
mydriasis: 1 hr, recover time: 3-6 hr.

Pharmacokinetics:
Absorption: Systemic absorption follows topical application.
Metabolism: Via intestinal monoamine oxidase to phenolic conjugates in the liver.
Excretion: Via urine (90%).

c) Indications and Uses:

Nasal congestion, Hypotensive states, Paroxysmal supraventricular tachycardia,
Mydriasis, Conjunctival decongestant.

d) Dosage and Administration:

Adult : PO Nasal congestion As HCl: 10 mg 4 hrly. Max: 60 mg/day. IV Hypotensive
states As 0.1% HCl soln: 100-500 mcg via inj, repeat as needed after at least 15 mins.
Severe: Infuse 10 mg at initial rate of ≤180 mcg/min, then reduce to 30-60 mcg/min
according to response. Paroxysmal supraventricular tachycardia As 0.1% HCl soln:
Initial max: 500 mcg, may increase subsequent doses by 100-200 mcg, up to 1 mg if
needed. IM/SC Hypotensive states As 0.1% HCl soln: Initial: 2-5 mg w/ further doses of
1-10 mg if needed. Rectal Haemorrhoids As cream/oint: Apply ≤4 times/day. As supp:
Insert 1 supp ≤4 times/day. Ophth Mydriasis As HCl: ≤10% soln: Instill 1 drop, may
 repeat in 10-60 mins as needed. Conjunctival decongestant As HCl: Usually 0.12%
soln: Instill 1-2 drops ≤4 times/day for ≤72 hr. Nasal Nasal congestion As 0.25-1% soln:
Instill/spray 4 hrly as needed.

e) Contraindications:
Hypertension, ventricular tachycardia. Oral: use with or within 14 days of MAOI therapy.
Ophthalmic: narrow-angle glaucoma.

f) Side-effects:
Anxiety, reflex bradycardia, tachycardia, arrhythmias, headache, cold
extremities/gangrene, hypertension, nausea, vomiting, sweating, weakness, fear,
restlessness, insomnia, confusion, irritability, psychotic states, dyspnoea, anorexia,
palpitations, extravasation causing tissue necrosis and sloughing, mydriasis, difficulty in
micturition and urinary retention, piloerection, increased salivation, hyperglycaemia, lactic
acidosis. Ophthalmic solutions may liberate pigment granules from the iris, corneal
clouding/damage.
Potentially Fatal: Increase in cardiac contractility, which may lead to angina or cardiac
arrest; severe hypertension leading to cerebral haemorrhage or pulmonary oedema.

g) Pregnancy and lactation:

Pregnancy Category C: Either studies in animals have revealed adverse effects on the
foetus (teratogenic or embryocidal or other) and there are no controlled studies in women
or studies in women and animals are not available. Drugs should be given only if the
potential benefit justifies the potential risk to the foetus.

h) Precautions:
Severe hyperthyroidism, severe ischaemic heart disease, DM, prostatic hyperplasia.
Rebound congestion in prolonged or excessive use of nasal drops. Use 10% eye drops in
extreme caution in infants, elderly, cardiac disease, significant hypertension, advanced
arteriosclerosis. Pregnancy and lactation. Over-the-counter cough and cold medications
should not be used in infants and children <2 yr.

i) Drug Interactions:
May increase hypertensive effect of beta-blockers (nonselective); MAOI potentiate
hypertension; methyldopa and TCA can increase the pressor response.

j) Overdose:
Vomiting, hypertension, palpitations, paresthesia, ventricular extrasystoles. Treatment is
supportive; in extreme cases, IV phentolamine may be used.
5. TECHNICAL DATA

a) Composition/Formula

I. Name of the Substance Specification Qty./Tablet

Active Substance (in mg)

Aliskiren INN 300

II. Excipients

Sodium Starch Glycolate BP 3.000

Lactose BP 10.40
Microcrystalline Cellulose BP 122.5
(Avicel PH 101)
Povidone K 30 BP 10.05

Magnesium Stearate BP 2.000

Colloidal Silicone Dioxide NF 2.000

b) Manufacturing Instructions:

1) Place the following materials into a Rapid Mixer Granulator (RMG) after passing through
#16 mesh screen (if necessary).
Sodium Starch Glycolate, Lactose, Micro crystalline Cellulose (Avicel PH101).
2) Add Povidone solution to step-1 and mix for 5 to 7 minutes until a granulating mass is
obtained.
3) Discharge the wet mass through to a FBD bowl at slow speed with both Agitator and
Chopper ON.
4) Dry the wet granules in fluid bed dryer at 700 C-750 C temperature. Keep the moisture
content up to 1%.
5) Pass the dried granules through #20 mesh screen and place the granules into double
cone blender.
6) Add Clomiphene Citrate to the step 4 and mix for 20 minutes.
7) Then add Magnesium Stearate and mix it for 1 minute.
8) Send some blend to QC for analysis.
9) Transfer the blend into a suitable tare container line with polybag with proper labeling and
lid.

c) Control Data for the Active material:

As per In House specification

d) Pharmacopoeia References for other constituents:

As that mentioned in the composition/formula

e) Control Data for finished product:

Appearance : Conform
Color : White
Shape : Round
 Hardness : 50N - 80N
Av. tablet wt. : 150 mg
DT : NMT 15 minutes
Label claim/Tablet : Each tablet contains Trifluoperazine Hydrochloride BP 1 mg.

f) Stability Data : To be submitted at the time of inclusion

g) Proposed Shelf Life : To be submitted at the time of inclusion

6. Pharmacological Data:

Not found

7. Toxicological Data:

Not Found

8. Clinical Data:

Not found

9. a) Number of manufacturers already manufacturing the product in Bangladesh:

None

b) Estimated market size of the product in Bangladesh: Tk. 10 million (approx.)

10. a) Proposed maximum retail price ( MRP) : To be submitted at the time of

inclusion.

b) Estimated price – per dose; per day treatment, cost for the recommended
course of treatment: To be submitted at the time of inclusion.
11. For locally manufactured drugs:

Signature: Signature:

MAHBUBUL KARIM A.K.M. ZAKARIA

Director, Technical Operations General Manager, R&D Formulation

Qualification: Qualification:
B. Pharm. (Hons.) B. Pharm (Hons.)
M. Pharm M. Pharm
.

Registration No. A – 811 Registration No. A – 1617

Date of joining in this company: Date of joining in this company:

1st April. 2004 1st May 2001

Total experience in Pharmaceutical Total experience in Pharmaceutical

Industry: Thirty Five Years Industry: Nineteen Years

12. In case of imported drugs : Not applicable

13. Date of Submission :

14. Additional Information (if any) : Not applicable