Butamirate Citrate BP 50 mg SR Tablet Composition

Sinecod forte Tablet: Each film coated sustained release tablet contains Butamirate
Citrate BP 50 mg.

Indication

Sinecod forteis indicated in dry cough of any etiology, pre and post operative cough and
whooping cough.

Mechanism of Action

Sinecod forte is a centrally acting cough suppressant which is neither chemically nor
pharmacologically related to opium alkaloids. In addition to its antitussive effect, Sinecod
forte also decrease the airways resistance.

Pharmacokinetics

Sinecod forte is rapidly and completely absorbed after oral administration. Maximum
concentration is reached within 9 hours with sustained release tablet. Sinecod forte is
extremely protein bound (about 95 %) and plasma elimination half-life is about 1 3 hours.
The active metabolites of Sinecod forte has also antitussive action. The metabolites are
mainly eliminated by urinary route.

Dosage and Administration

Adults: 2 to 3 tablets daily at 8 to 12 hours interval

Adolescents over 12 years of age: The recommended dose is 1 to 2 tablets daily.

6 Years and over: 1/2 tablet 1 to 2 times daily.

Contraindication

Hypersensitivity to the active ingredient.

Use in pregnancy

Sinecod forte should not be used during first trimester of pregnancy. During the
remainder of pregnancy, Butamirate Citrate can be used if definitely indicated.

Side Effects
Sinecod forte is well tolerated. In rare cases, skin rash, nausea, diarrhea, dizziness have
been reported. They disappear after reduction of the dosage or discontinuation of the
drug.

Overdose

Overdose may cause nausea, vomiting, diarrhea, dizziness and hypotension. The usual
emergency assistance should be taken: activated charcoal, saline laxative and
symptomatic treatment should be given.

Storage

Store in a cool and dry place away from light.

Presentation

Sinecod forteTablet: Each box contains 3X10s tablet in Alu-Alu blister pack.

Published on October 14, 2013 Filed under: Products; Tagged as: Sinecod forte
( butamirate citrate ) Drug - See also - Clinical use
Uses
Zinc has been used as a treatment for the common cold and for enhanced wound
healing, but evidence to support these indications is limited. Zinc also has applications
in pneumonia, diarrhea, male fertility, and Alzheimer disease.

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Dosing
Typical daily doses range widely from 12 to 150 mg daily as free zinc or up to 220 mg as
zinc sulfate. Avoid high-dose, long-term zinc supplementation.

Contraindications
None identified.

Pregnancy/Lactation
Zinc supplementation in pregnancy has been studied, with little cause for concern.

Interactions
Zinc may decrease the plasma concentrations of certain quinolone (eg, ciprofloxacin)
and tetracycline antibiotics, as with other divalent metals, such as calcium. Interference
with absorption and metabolism of iron, copper, and vitamin A has been described.

Adverse Reactions
The most common adverse reactions of oral zinc are nausea, bad taste, diarrhea,
vomiting, mouth irritation, and, rarely, mouth sores. Nasal and throat irritation may occur
with the zinc spray. There have been case reports of apparent zinc-induced copper
deficiency, immune system dysfunction, and myeloneuropathy. An increase in
genitourinary symptoms and prostate cancer has been related to zinc supplementation.

Toxicology
Information is lacking.

History
Zinc is an essential trace element necessary for normal human functioning. It serves as
an enzyme cofactor and protects cell membranes from lysis caused by complement
activation and toxin release. Zinc is not stored in the body; therefore, dietary intake is
required. Meat and seafood are rich in zinc. 1 , 2 The role of zinc in human health and
functioning has primarily focused on dietary supplementation for the promotion of health
and disease prevention. Aside from dietary zinc supplementation, zinc has been studied
for therapeutic use in the common cold, atopic eczema, psoriasis, acne vulgaris,
degenerative retinal lesions, age-related macular degeneration, inflammatory bowel
disease, and various other disorders. 3 , 4 , 5 , 6 , 7 , 8

Chemistry
Zinc is a metallic element available in various salt forms, including zinc gluconate, zinc
gluconate-glycine, zinc acetate, zinc ascorbate, zinc orotate, zinc citrate, zinc chloride,
and zinc sulfate. Zinc gluconate, zinc gluconate-glycine, and zinc acetate have been
studied most often in the lozenge form for the treatment of the common cold.

Uses and Pharmacology

Trials evaluating the efficacy of zinc versus placebo or a comparator drug are likely to
have methodological issues related to blinding, as the taste of the zinc preparation is
difficult to mask. Therefore, subjective outcomes are likely to be affected by bias. 9 , 10 ,
11

Age-related macular degeneration

Cochrane systematic reviews have been conducted for both the prevention of age-
related macular degeneration and slowing the progression of this disease. 12 , 13 No
evidence exists to support the role of zinc in the prevention of macular degeneration or
to delay its onset. 12 Zinc supplementation slows the progression of the disease, but
this beneficial effect should be weighed against the evidence of harm of long-term use
of zinc, such as genitourinary problems. 13

Alzheimer disease

Zinc is found in high concentration in brain tissue and is important in neurotransmission

across glutamatergic synapses. 14 Zinc ions have been associated with the formation of
beta-amyloid plaques that are characteristic of Alzheimer disease, but direct causality
has not been established. 11 , 14 , 15 Specific zinc-binding sites on the amyloid plaques
have been demonstrated, 16 and acceleration of aggregation of amyloid peptides by
zinc has been suggested. 1 Other authors describe a protective role for zinc, noting that
zinc deficiency is a common observation in elderly patients, and suggest that loss of
zinc homeostasis may be important in Alzheimer disease. 1 , 11 , 16 , 17 Clinical trials
are limited but focus on the chelation of free metal ions, which may prevent binding to
beta-amyloid plaques. 11 , 18 , 19

Diabetes

A Cochrane review of high-quality trials evaluating the value of zinc in the prevention of
type 2 diabetes found no evidence to support the use of zinc supplementation. 9 Zinc is
thought to stimulate insulin action and insulin receptor activity. Trials evaluating the
effect of zinc supplementation in the management of type 2 diabetes have found
conflicting results, including no difference in serum zinc levels, 20 no effect on glucose,
21 reductions in total cholesterol and triglycerides, 21 and improved antioxidant status.
22 , 23

Diarrhea (in children)

A Cochrane systematic review of clinical trials found evidence to support the use of zinc
in the management of acute and persistent diarrhea in children older than 6 months of
age. 24 A decrease in the duration of diarrhea has been shown. Insufficient data are
available from these trials on mortality outcomes, and vomiting was found to be more
common among zinc-treated children than placebo-treated children.

Fertility

Several trials have evaluated the relationship between zinc deficiency and male fertility,
but direct causality is not established. 25 Subfertility is seen in men with Crohn disease.
Decreased serum zinc levels have been found in these patients. 26 Other investigators
suggest that seminal zinc levels are more important than blood zinc content. The ratio of
copper/zinc has been found to be higher in men with sperm of abnormal motility. 27
Among healthy volunteers, dietary intake of zinc did not appear to be associated with
semen quality. 28

Animal data

In vitro studies in salmon sperm found negative effects of zinc on DNA at higher
concentrations, despite previously demonstrated positive antioxidant effects. 29 Similar
positive results have been reported for the effect of zinc on sperm fragmentation, and
negative findings on sperm head chromatin decondensation. 30 In female rabbits, a zinc
deficiency was correlated with abnormal estrous cycles, a disinterest in males, and an
inability to conceive. 29

Clinical data

Trials have been conducted to evaluate the effect of zinc in fertile and subfertile men,
alone and in combination with folic acid. 25 , 31 , 32 A difference in total healthy sperm
count was found, but changes in serum zinc concentration could not be correlated to
this effect. 25 In large trials investigating the effect of antioxidants and vitamin/mineral
supplements, an increased risk of some prostate cancers was associated with long-term
administration of zinc greater than 100 mg/day. 33 Case reports show that zinc
supplementation in women results in improved fertility. 29

Respiratory tract infections

Zinc lozenges and zinc spray are designed to release zinc ions in the oropharyngeal
cavity. The exact mechanism of action of zinc ions is still controversial but may involve a
combination of actions. According to in vitro studies, zinc ions interfere with rhinoviral
capsid proteins, thereby altering protease activity. 34 , 35 , 36 However, zinc ions have
not been shown to affect mature rhinoviruses. It has also been suggested that zinc may
interfere with viral docking and the resulting inflammatory process. 37 Another
mechanism for zinc may involve the inhibition of histamine release from mast cells and
basophils. 38 Effects on immune function remain unclear and may be dependent on the
dosage of zinc administered, with higher dosages being detrimental. 33 , 39 , 40 , 41 ,
42 , 43

Upper respiratory tract infections/common cold

Methodological quality of the clinical trials is highly variable, making meta-analysis

difficult. An earlier Cochrane systematic review (now withdrawn pending an update) was
conservative in its recommendations regarding the role of zinc in the management of
the common cold. Numbers needed to benefit ranged from 4 to 6, while numbers
needed for harm (irritation of the oral mucosa and taste distortions) were almost
equivalent (numbers needed to treat for one person to harm = 8). 44

Other meta-analyses determined that zinc as a lozenge was not superior to placebo with
regard to symptom duration or severity but noted wide variations in methodologies,
including issues related to blinding. 10 , 45 , 46 , 47 , 48 As a nasal spray, zinc
decreased symptom duration in one trial but was not different from placebo in another.
49 , 50

Lower respiratory tract infections/pneumonia

Trials among residents of nursing homes for elderly patients have found a decrease in
incidences of infections and oxidative stress markers and increases in plasma zinc
levels with moderate zinc supplementation (15 to 45 mg/day). 39 , 40 In a large,
multicenter study of 33 nursing homes, supplemental zinc was associated with a
decrease in the incidence and duration of pneumonia and a decrease in antibiotic use.
51

A clinical trial showed a decreased duration of pneumonia and reduced length of

hospital stay in children treated with supplemental zinc 20 mg/day. 52 Outcome
measures such as chest indrawing, respiratory rate, and hypoxia were also improved.
Baseline serum zinc was not measured. Other authors suggest a more conservative
approach, as mixed results have been found, and suggest zinc may even be harmful in
children with bacterial pneumonia. 53 , 54

Wound healing

Nutritional zinc deficiency has been associated with decreased wound healing by
damaging epidermal cells and altering polymorphonuclear cell function, natural killer cell
function, and complement activity. 41 , 42 , 43 Delayed healing after burns because of
micronutrient deficiency has been reported. 55 Supplementation with selenium, copper,
and zinc has been associated with increased circulating plasma and skin tissue ions,
enhanced antioxidant status, and improved clinical outcomes in a small trial (n = 21)
among burn patients. 56 A Cochrane systematic review found no evidence to support
the role of oral zinc sulfate in healing chronic venous ulcers. 57 , 58

Other uses
Acrodermatitis enteropathica

Case reports exist of rapid resolution of dermatological symptoms of this rare genetic
disorder in which zinc binding in the intestine is deficient. 59 , 60

Epilepsy

The role of zinc remains controversial. Intracerebral zinc injections have been used
experimentally to induce seizures. Animal studies suggest that lower zinc levels might
modulate synaptic activity and be protective. 18 A study of serum zinc levels in pediatric
febrile seizures found a difference in children with low serum zinc levels and seizures
when compared with age-matched controls. 61

Liver disease

The role of zinc in liver disorders has been reviewed. 62 , 63 However, clinical trials are
lacking.

Mucositis

A Cochrane systematic review found only one well-controlled trial that met inclusion
criteria evaluating the effect of zinc supplementation on cancer-related mucositis. 64
The small trial (n = 27) found a difference in severe mucositis versus placebo. A further
trial using zinc 75 mg/day found a difference in the time to develop mucositis and a
reduction in the development of more severe grades. 65

Taste disorders

Taste disorders were common in elderly patients and correlated with low serum zinc
levels; taste disorders were resolved in up to 70% of cases, with zinc administered daily
(elemental zinc 34 mg) in one trial, 66 but not in another. 67

Wilson disease

Zinc salts (150 to 200 mg/day) are used in this rare autosomal recessive disease, in
which copper accumulates in the liver, brain, and kidneys, and manifests as liver
disease and neuropsychiatric symptoms. 68

Dosage
Zinc has been studied in clinical trials for a variety of diseases. Typical daily doses
include 12 to 150 mg daily as free zinc, or up to 220 mg as zinc sulfate. 11 , 24 , 40 ,
51 , 64 Reviews of the role of zinc supplementation suggest a conservative approach
that recognizes a differential effect, with lower doses having positive effect and higher
dosages being potentially harmful, as well as the potential for displacement of other
metal ions. 69

Bioavailability of zinc is variable, with absorption generally better than aqueous

solutions. 70

Pregnancy/Lactation
Zinc supplementation in pregnancy has been studied. A Cochrane review found a slight
reduction in incidence of preterm births, but no effect on low birth weight. 71 No
differences were found for maternal or other neonatal outcomes. The reviewers favor
addressing overall nutritional status rather than focusing only on maternal zinc status.

Interactions
Ingestion of zinc salts has been associated with a decrease in the absorption of orally
administered tetracyclines 72 , 73 , 74 and quinolone antibiotics (eg, ciprofloxacin,
norfloxacin), 75 , 76 possibly decreasing the anti-infective response.

Interference with absorption and metabolism of iron, copper, and vitamin A has been
described and is relevant considering the coexistence of other micronutrient deficiencies
common in zinc deficiency. 69

Adverse Reactions
The most common adverse reactions reported in clinical trials for zinc lozenges were
nausea, bad taste, diarrhea, vomiting, mouth irritations, and mouth sores. For zinc
spray, nasal irritation and throat irritation were reported most often.

There are case reports of high-dose, chronic zinc supplementation resulting in severe
copper deficiencies, and manifesting as sideroblastic anemia and neutropenia. 60 , 77
Immune dysfunction and myelopolyneuropathies consequent to zinc overload have been
described. 33 , 78 An increase in genitourinary symptoms and some prostate cancers
has been found in large trials evaluating the role of zinc in age-related eye disease. 33

Toxicology
Information is lacking. 79

Bibliography
1. Vasto S, Candore G, List F, et al. Inflammation, genes and zinc in Alzheimer's
disease. Brain Res Rev . 2008;58(1):96-105.
2. Pasternak CA. A novel form of host defence: a membrane protection by Ca 2+

and Zn 2+ . Biosci Rep . 1987;7(2):81-91.