SINEQUAN

The supervision by: Made by:

Dr.Hasan Khudhair Sajid Ali Khudhair

*Tikrit University/College of Medicine.Year2019-2020 /second

stage pharmacology report about Sinquan.
DESCRIPTION
SINEQUAN (doxipin hydrochloride) is one of a class of psychotherapeutic
agents known as dibenzoxepin tricyclic compounds. The molecular formula of
the compound is C19H21NO•HCl having a molecular weight of 316. It is a
white crystalline solid readily soluble in water, lower alcohols and chloroform.
Inert ingredients for the capsule formulations are: hard gelatin capsules
(which may contain Blue 1, Red 3, Red 40, Yellow 10, and other inert
ingredients); magnesium stearate; sodium lauryl sulfate; starch.
Inert ingredients for the oral concentrate formulation are: glycerine ;
methylparaben; Peppermint oil; propylparaben; water.
Chemistry
SINEQUAN (doxepin HCl) is a dibenzoxepin derivative and is the first of a
family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric
mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-
dimethyl-, hydrochloride.
ACTIONS

The mechanism of action of SINEQUAN (doxepin HCl) is not definitely known.

It is not a central nervous system stimulant nor a monoamine oxidase inhibitor.
The current hypothesis is that the clinical effects are due, at least in part, to
influences on the adrenergic activity at the synapses so that deactivation of
norepinephrine by reuptake into the nerve terminals is prevented. Animal
studies suggest that doxepin HCl does not appreciably antagonize the
antihypertensive action of guanethidine. In animal studies anticholinergic,
antiserotonin and antihistamine effects on smooth muscle have been
demonstrated. At higher than usual clinical doses, norepinephrine response
was potentiated in animals. This effect was not demonstrated in humans.
At clinical dosages up to 150 mg per day, SINEQUAN can be given to man
concomitantly with guanethidine and related compounds without blocking the
antihypertensive effect. At dosages above 150 mg per day blocking of the
antihypertensive effect of these compounds has been reported.
SINEQUAN is virtually devoid of euphoria as a side effect. Characteristic of
this type of compound, SINEQUAN has not been demonstrated to produce the
physical tolerance or psychological dependence associated with addictive
compounds.

INDICATIONS

SINEQUAN is recommended for the treatment of:

1. Psychoneurotic patients with depression and/or anxiety.
2. Depression and/or anxiety associated with alcoholism (not to be taken
concomitantly with
alcohol).
3. Depression and/or anxiety associated with organic disease (the possibility
of drug
interaction should be considered if the patient is receiving other drugs
concomitantly).
4. Psychotic depressive disorders with associated anxiety including
involutional depression
and manic-depressive disorders.

The target symptoms of psychoneurosis that respond particularly well to

SINEQUAN include anxiety, tension, depression, somatic symptoms and
concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and
worry.
Clinical experience has shown that SINEQUAN is safe and well tolerated even
in the elderly patient. Owing to lack of clinical experience in the pediatric
population, SINEQUAN is not recommended for use in children under 12 years
of age.

Proper Use
Take this medicine only as directed by your doctor to benefit your condition as
much as possible. Do not take more of it, do not take it more often, and do not
take it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide. Read and follow the
instructions carefully. Ask your doctor if you have any questions.
If you are using the Sinequan® oral liquid or capsule once a day, you may take
it at bedtime.
To use the Sinequan® oral liquid:
● Measure the dose with the calibrated dropper that comes with the

medicine.
● Mix each dose with about one-half glass (4 ounces) of water, whole or

skimmed milk, orange juice, grapefruit juice, tomato juice, prune juice, or
pineapple juice. Do not mix this medicine with grape juice or carbonated
beverages (soda pop). Mix the medicine just before taking the dose. Do
not prepare it ahead of time.
To use the Silenor® tablet:
● Do not take this medicine within 3 hours of a meal. It may not work as

well, or it might make you sleepy the next day if you take it with or right
after a meal.
● Take the tablet 30 minutes before going to bed, when you are ready to go
 to sleep.
● Do not take the medicine unless you can get a full night's sleep (7 to 8
hours). If you wake up too soon, you may feel drowsy from the medicine.

Dose

The dose of this medicine will be different for different patients. Follow your
doctor's orders or the directions on the label. The following information
includes only the average doses of this medicine. If your dose is different, do
not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the
medicine. Also, the number of doses you take each day, the time allowed
between doses, and the length of time you take the medicine depend on the
medical problem for which you are using the medicine.
● For oral dosage forms (capsules or solution):

○ For depression or anxiety:

◆ Adults and children 12 years of age and older—At first, 75

milligrams (mg) once a day or in divided doses during the day.

Your doctor may adjust your dose as needed. However, the
dose is usually not more than 150 mg per day.
◆ Children younger than 12 years of age—Use is not

recommended.
● For oral dosage form (tablets):

○ For insomnia:

◆ Adults—6 milligrams (mg) once a day.

◆ Older adults—At first, 3 mg once a day. Your doctor may adjust

your dose as needed.

◆ Children—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is

almost time for your next dose, skip the missed dose and go back to your
regular dosing schedule. Do not double doses.

Use & Storage

Store the medicine in a closed container at room temperature, away from

heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you
do not use.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be

weighed against the good it will do. This is a decision you and your doctor will
make. For this medicine, the following should be considered:

References :
1. FDA
2. Lippincott Illustrated
3. WHO
4. Medscape
5. Drugs.com